57 Quality Engineering jobs in Remote - United States.

Hiring now: Regulatory Spec Fragrance @ Osmo, Vice President Technical @ Parexel, Sr Medical Devices Safety @ Anteris Te, External Site Lead @ Biogen, Associate Dir Inspection @ Regeneron , Mgr Regulatory Consulting @ Syneos Hea, Internal Nuclear Qa Audit @ Dte Electr, Dirsr Dir Regulatory Affa @ Bridgebio , Sr Mgr Health Systems Lab @ Quest Diag, Clinical Success Mgr Radm @ Radformati.Explore more at jobswithgpt.com.

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compliance (13) project management (10) regulatory compliance (9) quality assurance (8) Compliance (7) medical devices (7) FDA (6) Project Management (6) Regulatory Affairs (6) regulatory submissions (5)

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United States (57)
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Osmo

Regulatory Specialist, Fragrance Manufacturing United States
Skills & Focus: regulatory compliance, fragrance, SDS preparation, IFRA, REACH, FDA, EPA, technical documentation, product registrations, risk assessments
About the Company: Osmo is a digital olfaction company focused on enhancing human health and wellbeing through the power of smell.
Experience: Minimum of 3-5 years of experience in regulatory affairs
Type: Full time

Parexel

Vice President, Technical - Medical Device United States
Skills & Focus: consulting, regulatory, affairs, clinical, operations, strategy, biologics, medical, device, biostatistics
Regulatory Operations Submissions - various levels United States
Skills & Focus: Regulatory, Consultant, Remote, Biologics, Project Management, Technical, Clinical, FSP, Associate, Labeling

Anteris Technologies

Senior Medical Devices Safety Specialist United States
Skills & Focus: Safety Monitoring, Clinical Trial Safety, Risk Assessment, Post-Market Surveillance, Regulatory Compliance, Medical Device Safety, Adverse Event Reporting, Safety Management Plan, Quality Assurance, Compliance
About the Company: Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. Our mission is to forge new frontiers in cardiac care by …
Experience: Minimum of 5 years’ experience in medical device safety.
Type: Full-time
Benefits: Competitive compensation package, including salary, performance-based bonuses, and stock options. Career development op…

Biogen

External Site Lead United States
Skills & Focus: manufacturing, CDMO, process controls, scientific data analysis, Continuous Process Verification, optimization, compliance, vendor engagement, project metrics, continuous improvement
About the Company: Biogen is a biotechnology company specializing in the development of therapies for neurological diseases.
Type: Remote

Regeneron Pharmaceuticals Inc.

Associate Director Inspection Management (GCP) United States
Skills & Focus: GCP, GVP, GLP, inspections, stakeholder engagement, regulatory compliance, quality management, clinical trials, training, risk mitigation
Experience: 10 years
Salary: $154,800.00 - $252,800.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Syneos Health

Mgr, Regulatory Consulting United States
Skills & Focus: regulatory submissions, project management, compliance, clinical reports, budgeting, staff management, pharmaceutical, medical writing, IND, PMA
About the Company: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
Experience: Moderate experience in regulatory with demonstrated experience in contributing to the preparation of regulatory submissions.
Salary: $79,800-139,600 USD
Type: Full-time
Benefits: Health benefits to include Medical, Dental, and Vision, Company match 401k, eligibility to participate in Employee Stoc…

Dte Electric Company

Internal Nuclear QA Auditor United States
Skills & Focus: nuclear safety, internal audits, quality assurance, compliance, vendor assessment, regulatory requirements, corrective actions, auditing, engineering, radiation protection
About the Company: DTE is one of the nation’s largest diversified energy companies. Our electric and gas companies have fueled our customer’s homes and Michigan’s progress for mo…
Experience: Must have a Bachelor's Degree or SRO license/certification plus 3 years commercial nuclear power plant experience, or completion of an Associate's Degree plus 5 years commercial nuclear power plant experience, or High School Graduate plus 9 years commercial nuclear power plant experience.

Bridgebio Pharma

Director/Sr. Director, Regulatory Affairs - CMC United States
Skills & Focus: Regulatory Affairs, CMC, NDA, MAA, Documentation, Submissions, Compliance, Health Authority, Drug Development, Quality Control
About the Company: BridgeBio Pharma is a commercial stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or…
Experience: Successful experience leading Regulatory CMC activities for multiple regulatory filings in pre-and post-approval settings, including experience filing an NDA/MAA for a new chemical entity.
Salary: $210,000 - $315,000 USD
Type: Full-time
Benefits: A robust and market-competitive compensation & benefits package including base pay, annual performance bonus, company e…

Parexel

Vice President, Technical - Medical Device United States
Skills & Focus: Regulatory Affairs, Consulting, Medical Device, Clinical, Technical, Senior Consultant, FSP, Temporary, Remote, Labeling Operations

Quest Diagnostics

Sr. Manager, Health Systems Lab Operation United States
Skills & Focus: Healthcare, Laboratory Operations, Project Management, Clinical, Operational Excellence, Stakeholder Management, Quality Control, Continuous Improvement, Patient Care, Matrix Environment
About the Company: Quest Diagnostics is a leading provider of diagnostic testing, information, and services that help patients and practitioners manage health and wellness.
Experience: 7 or more years managerial experience in the laboratory industry
Type: Full-Time
Benefits: Comprehensive total rewards package including medical, dental, vision, annual incentive plans, and 401(k) matching up t…

Parexel

Various Positions in Consulting United States
Skills & Focus: Regulatory Affairs, Clinical Research, Medical Device, Consulting, Biologics, Project Management, Submissions, CMC, Drug Products, Remote

Radformation

Clinical Success Manager - RadMachine Therapy United States
Skills & Focus: machine QA, treatment planning, workflow, clinical success, standardization, mentoring, relationship development, feedback incorporation, efficiency improvement, Radiation Oncology
About the Company: Radformation aims to create a system where any patient anywhere can receive the same high-quality care by automating and standardizing the treatment planning w…
Type: Full-time

Sgs

Product Assessor United States
Skills & Focus: Product Assessment, Technical File Review, Medical Device Directive, Regulation Compliance, CE Marking, Training and Qualification, Risk Minimization, KPI Adherence, Stakeholder Communication, Service Delivery
About the Company: SGS is a global leader in inspection, verification, testing and certification services.
Experience: Highly skilled and detail-oriented.
Type: Full-time
Product Assessor United States
Skills & Focus: Product Assessment, Technical File Review, Medical Device Directive, Regulation Compliance, CE Marking, Training and Qualification, Risk Minimization, KPI Adherence, Stakeholder Communication, Service Delivery
About the Company: SGS is a global leader in inspection, verification, testing and certification services.
Experience: Highly skilled and detail-oriented.
Type: Full-time

Amgen

Material Compliance Associate United States
Skills & Focus: Material Approval and Compliance, quality check, Veeva, submission documents, FDA requirements, project management, copy-editing, marketing materials, cross-functional teams, collaboration
About the Company: Amgen is a biotechnology company that pioneers innovative medicines for patients with serious illnesses.
Experience: Bachelor’s degree OR Associate’s degree and 4 years of Marketing Communications Project Management / Copy-Editing experience OR High school diploma, or GED, and 6 years of Marketing Communications Project Management / Copy-Editing experience
Salary: 70,403.00 USD - 87,441.00 USD
Type: Full-time
Benefits: Comprehensive employee benefits package including health and welfare plans, retirement savings plan, life and disabilit…

Syneos Health

Principal Quality Auditor United States
Skills & Focus: Quality Auditor, REMS, pharmaceutical auditing, GCP, GMP, Good Clinical Practice, external audits, communication skills, documentation skills, risk evaluation
About the Company: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medica…
Experience: 5-8 years
Salary: $104k to $135k
Type: Full-time
Benefits: Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time.

Apogee Therapeutics, Inc.

Director, Computer System Validation - Quality Assurance (CSV QA) United States
Skills & Focus: computing system validation, quality assurance, biotechnology, pharmaceutical, regulatory compliance, risk management, data integrity, leadership, cross-functional collaboration, validation documentation
About the Company: Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonar…
Experience: Minimum of 10 years of experience in computer system validation (CSV) within a biotechnology, pharmaceutical, and/or medical device industry with at least 3 years in a leadership role focused on quality assurance.
Salary: $200,000 - $225,000/year
Type: Full-time
Benefits: Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunit…

Radformation

QA Manager United States
Skills & Focus: Radiation Oncology, QA Manager, treatment planning, quality assurance, medical physicist, product quality management, testing, regulatory documentation, treatment optimization, clinical skills
About the Company: Radformation specializes in Radiation Oncology Cancer treatment workflow automation, aiming to standardize care and improve treatment planning processes. Their…
Experience: Medical physicist with experience in radiation therapy and quality assurance in Radiation Oncology.
Salary: NA
Type: Full-time
Benefits: NA

Bd

Senior Specialist/Manager Regulatory Affairs United States
Skills & Focus: regulatory affairs, FDA, medical devices, compliance, pharmaceutical, product registration, Good Clinical Practices, project management, communication skills, organizational skills
About the Company: BD is one of the largest global medical technology companies in the world, improving medical discovery, diagnostics and the delivery of care.
Experience: Minimum of five years of experience in pharmaceutical industry
Salary: Competitive
Type: Full-Time
Benefits: Healthcare, 401(k)/Retirement Plans, Employer Matching, Tuition Reimbursement, Paid Time Off

Ardelyx

Associate Director, Pharmacovigilance United States
Skills & Focus: pharmacovigilance, drug safety, regulatory compliance, case processing, quality assurance, adverse event reporting, SOPs, aggregate reports, internal audits, vendor management
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 8 – 10 years
Salary: $180,000-$220,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks of paid parental leave, health plans, life insurance and disability,…

Mcra, An Iqvia Business

Associate Director/Director, Cardiovascular Regulatory Affairs United States
Skills & Focus: regulatory submissions, regulatory strategy, cardiac electrophysiology, regulatory bodies, project management, mentoring, clinical research, healthcare compliance, quality assurance, medical device
About the Company: MCRA is a leading medical device advisory firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, healthcar…
Experience: Experience in regulatory affairs, specifically in cardiac electrophysiology, as well as management experience.
Associate Director/Director, Cardiovascular Regulatory Affairs United States
Skills & Focus: regulatory submissions, regulatory strategy, cardiac electrophysiology, regulatory bodies, project management, mentoring, clinical research, healthcare compliance, quality assurance, medical device
About the Company: MCRA is a leading medical device advisory firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, healthcar…
Experience: Experience in regulatory affairs, specifically in cardiac electrophysiology, as well as management experience.

Apogee Therapeutics

Associate Director, Clinical Quality Assurance United States
Skills & Focus: clinical quality assurance, GCP compliance, biotechnology, audit experience, quality metrics, CAPAs, clinical operations, regulatory standards, continuous improvement, team collaboration
About the Company: Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pu…
Experience: 8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function.
Salary: $175,000-$195,000/ year
Type: Full-time
Benefits: Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunit…

Amgen

Global Safety, Senior Manager United States
Skills & Focus: Safety, Pharmacovigilance, Compliance, Patient support programs, Data collection, Cross-functional relationships, Monitoring compliance, Project management, Regulatory requirements, Audits
About the Company: At Amgen, we have helped pioneer the world of biotech since 1980, focusing on serving patients living with serious illnesses in therapeutic areas such as Oncol…
Experience: Doctorate degree and 2 years of Safety experience or Master’s degree and 4 years of Safety experience or Bachelor’s degree and 6 years of Safety experience or Associate’s degree and 10 years of Safety experience or High school diploma/GED and 12 years of Safety experience
Salary: 148,053.00 USD - 172,515.00 USD
Type: Full time
Benefits: Comprehensive employee benefits package, including Retirement and Savings Plan with generous company contributions, gro…

Baxter

QA Specialist United States
Skills & Focus: quality, compliance, manufacturing, healthcare, medical devices, innovation, sustainability, patient care, teamwork, diversity
About the Company: Baxter is a global medical device and healthcare solutions company, dedicated to designing innovative therapies that save and sustain lives.
Type: Full-time
Benefits: Comprehensive benefits options reflect the value we place in our employees.

Sikich

QMS Project Manager United States
Skills & Focus: Project Manager, Client Implementation, Life Science, Pharmaceutical, Medical Device, Project Management, Software Delivery, Agile, Stakeholder Communication, Risk Management
About the Company: Sikich is a global company specializing in Accounting, Advisory, and Technical professional services.
Experience: 7+ years of IT work experience (software implementation), including 5 + years of project management experience within the Life Science, Pharmaceutical and Medical Device industries.
Salary: $112,000
Benefits: Flexible Time Off (FTO) Policy, wellness program, health, dental, vision, life insurance options, 401(k) with employer …

Guardanthealth

Medical Writing Manager, Publications United States
Skills & Focus: medical writing, publications, scientific manuscripts, clinical research, compliance, collaboration, literature reviews, cross-functional teams, quality control, project management

Dianthus Therapeutics

Director, MSAT United States
Skills & Focus: Process Performance Qualification, manufacturing, upstream development, downstream processes, technology transfer, regulatory compliance, analytical support, leadership, mentorship, quality control
About the Company: Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodi…
Experience: 8+ years of relevant industry experience

Perrigo

CMC Regulatory Affairs Project Manager United States
Skills & Focus: CMC Regulatory Affairs, project management, healthcare products, medical devices, cosmetics, regulatory strategies, product development, quality management, technical documentation, compliance
About the Company: We are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the …
Experience: Minimum of 7 years of relevant work experience, preferably in CMC Regulatory Affairs or R&D.
Benefits: Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career dev…

Peloton

Sr. FATP Supplier Quality Engineer - Contractor United States
Skills & Focus: Supplier Quality Engineer, Quality Management Systems (QMS), ISO9001, Supplier audits, Continuous Improvement, 8D problem-solving, GMP, Lean/Six Sigma, Process validation, CAD tools
About the Company: Peloton (NASDAQ: PTON) provides Members with expert instruction, and world class content to create impactful and entertaining workout experiences for anyone, a…
Experience: 5+ years of experience working as a supplier quality engineer in a similar fast-paced industry
Type: Contract

Bridgebio Pharma

Sr. Director, Global Regulatory Affairs Labeling United States
Skills & Focus: regulatory affairs, labeling strategies, compliance, drug development, pharmaceutical, leadership, project management, communication, US product labeling, global labeling activities
About the Company: BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic dise…
Experience: 10+ years of pharmaceutical, regulatory or industry-related experience; 8 years of pharmaceutical experience; Proven 3 years in a leadership role
Salary: $245,000 - $315,000 USD
Type: Full-time
Benefits: Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retir…

Sgs

Senior Medical Device Auditor United States
Skills & Focus: Senior Medical Device Auditor, audits, ISO 13485, MDSAP, MDD, MDR, medical devices, audit teams, certification, training
Experience: Must have experience with ophthalmology medical devices

Iqvia

Associate Director, IT Compliance United States
Skills & Focus: IT Compliance, Validation, GxP, regulations, risk management, audit, client service, regulatory guidance, Foster system lifecycle, Quality Assurance
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Substantial experience in healthcare, life sciences (Pharma, CROs), related product or service industry.
Type: Full time
Benefits: Benefits programs are designed to meet your total well-being needs so you can thrive at work and at home.
External TMF Manager, sponsor-dedicated United States
Skills & Focus: TMF management, clinical trial, quality review, regulatory compliance, data analytics, established timelines, TAF health, documentation, cross-functional teams, GCP
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Minimum 5 years pharmaceutical / biotechnology industry experience, Minimum 3 years records management experience in a GCP-regulated environment.
Type: Full time
Benefits: Benefits programs are designed to meet your total well-being needs so you can thrive at work and at home.

Dentsply Sirona, Inc

Director Center of Excellence Clinical Research United States
Skills & Focus: clinical research, dental industry, product development, ISO 14155, MDR, medical device, team management, investigator-initiated studies, scientific communication, regulatory compliance
About the Company: Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the …
Experience: Minimum of 10+ years of experience in clinical research with a focus on dentistry.

Bd

Staff Regulatory Affairs Specialist United States
Skills & Focus: regulatory affairs, medical devices, FDA regulations, healthcare, registration, compliance, quality management systems, product registration, regulatory inspections, risk assessments
About the Company: BD is one of the largest global medical technology companies in the world, advancing the world of health™.
Experience: 5 years experience working within a Registration Department or similar role preferred
Salary: Competitive
Type: Full-Time
Benefits: Healthcare, Healthcare FSA, 401(k)/ Retirement Plans, Employer Matching, Tuition Reimbursement, Paid Time Off

Novo Nordisk

Senior Quality Control Professional (GMP) United States
Skills & Focus: Quality Control, GMP, Pharmaceutical, Compliance, Quality Management System, Audit, Training, Deviation, Inspection, Quality Assurance
About the Company: Novo Nordisk is a global healthcare company with over 100 years of innovation in diabetes care. It also addresses obesity, hemophilia, growth disorders and oth…
Experience: Demonstrated solid experience in the pharmaceutical industry, with a focus on production, quality control laboratories or quality assurance.

Becton, Dickinson And Company

Senior Manager - Quality Engineering United States
Skills & Focus: Quality Engineering, Quality Management System, Compliance, Medical Devices, New Product Development, Continuous Improvement, Technical Support, Team Leadership, Quality Compliance, Customer Requirements
About the Company: BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the …
Experience: Fifteen years of proven experience in quality design and technical knowledge; five years of people management experience.
Salary: Competitive
Type: Full-Time
Benefits: Competitive package of compensation and benefits.

Baxter

Research and Development Jobs United States
Skills & Focus: Research, Development, Healthcare, Engineering, Innovation, Medical Devices, Quality, Clinical, Manufacturing, Technology
About the Company: Baxter is a company that provides various healthcare solutions and is dedicated to saving and sustaining lives.
Type: Full time

Bd

Senior Specialist, Regulatory Affairs United States
Skills & Focus: Regulatory Affairs, Medical Devices, FDA, Compliance, ISO, Documentation, Technical File, Risk Management, Quality Management System, Product Development
About the Company: BD is one of the largest global medical technology companies in the world, advancing the world of health™ by improving medical discovery, diagnostics, and the …
Experience: Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices
Salary: $121,100.00 - $199,800.00 USD Annual
Type: Full-Time
Benefits: Competitive compensation and benefits programs, emphasis on associate well-being and development.

Amgen

Senior Material Compliance Associate United States
Skills & Focus: Material Compliance, Project Management, Marketing Communications, Brand Marketing, Compliance, Leadership, Pharmaceutical, Collaboration, Adobe products, Veeva PromoMats
About the Company: At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all…
Experience: Master's degree OR Bachelor's Degree and 2 years of Marketing Communications Project Management experience OR Associate degree and 6 years of Marketing Communications Project Management experience OR High school diploma, or GED, and 8 years of Marketing Communications Project Management experience
Salary: 82,984.00 USD - 103,629.00 USD
Type: Full time
Benefits: A comprehensive employee benefits package including health and welfare plans, retirement and savings, life and disabili…

Biomarin Pharmaceutical Inc.

Director, Product Quality Leader United States
Skills & Focus: product quality, CMC, quality assurance, regulatory guidelines, clinical development, commercialization, risk management, quality strategy, stakeholder engagement, cross-functional teamwork
About the Company: BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future o…
Experience: 12+ years of experience in Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry

Cardinal Health

Director, Design Quality Engineering United States
Skills & Focus: Quality Management, Design Quality Management, Regulatory compliance, Product development, Risk management, Quality control, Process improvement, Strategic planning, Cross-functional collaboration, Medical device industry
About the Company: Cardinal Health, a global healthcare services and products company, provides pharmaceutical distribution and medical product solutions.
Experience: 12+ years of experience highly preferred
Salary: $114,200-$184,380
Type: Full time
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being: Medical, dental and vi…

Sgs

Medical Devices Technical Director, Business Assurance, North America United States
Skills & Focus: medical devices, technical file review, audit, operational efficiency, customer service, strategic plan, training, resource requirements, go-to-market strategies, certification services
About the Company: SGS is a leading inspection, verification, testing and certification company, recognized as the global benchmark for quality and integrity.
Type: Full-time

Baxter

Instrumentador (a) Quirurgico (a) United States
Skills & Focus: medical devices, healthcare, innovation, patient care, sales, marketing, clinical education, supply chain, manufacturing, quality assurance
About the Company: Baxter is a healthcare company that provides a range of medical products and solutions aimed at saving and sustaining lives.
Type: Full time
Benefits: Comprehensive benefits options

Becton, Dickinson And Company

Change Control Coordinator United States
Skills & Focus: Change Control, Design Change, Quality Assurance, Regulatory Compliance, ISO 13485, QSR, MDR, Project Management, Engineering, Medical Technology
About the Company: BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and…
Experience: Minimum of 3 years in quality engineering/system processes
Salary: Competitive
Type: Full-Time
Benefits: Healthcare, FSA, Employer Matching, Tuition Reimbursement, Professional Development, Maternity and Paternity Leave, Pai…

Veeva Systems

Consultant - Pharmacovigilance/Safety Systems Implementation United States
Skills & Focus: Pharmacovigilance, Safety, Implementation, Life Sciences, Customer Success, Drug Safety, GxP software, Configuration, Validation, Training
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: 3+ years of experience in Life Sciences, Healthcare, or an adjacent Safety industry
Salary: $80,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

Alten Technology Usa

QMS Implementation Specialist United States
Skills & Focus: QMS, ISO 9001, AS9100, compliance, quality policies, procedures, documentation, internal audits, KPIs, aerospace manufacturing
About the Company: ALTEN Technology USA is an engineering company that provides solutions for engineering, technology, and product development projects, helping clients develop p…
Experience: Minimum 5 years of experience in a relevant field, with aerospace manufacturing experience.
Salary: $105,000-$110,000
Type: Full-time
Benefits: Comprehensive benefits including medical, dental, and vision insurance, a 401(k) plan with employer matching, paid time…

Bd

Senior Regulatory Manager - Hybrid United States
Skills & Focus: Regulatory Affairs, Medical Devices, NPD, FDA, ISO, EU MDR, CAPAs, Clinical Trials, Post-market activities, Quality Control
About the Company: BD is one of the largest global medical technology companies in the world, advancing the world of health by improving medical discovery, diagnostics, and the d…
Experience: Minimum 5 years of relevant experience in medical devices or pharmaceuticals, preferably within Regulatory Affairs.
Salary: $162,300.00 - 267,800.00 USD Annual
Type: Full-Time
Benefits: Healthcare, Healthcare FSA, 401(k)/Retirement Plans, Employer Matching, Tuition Reimbursement, Paid Time Off.

Johnson & Johnson

Submissions & Regulatory Intelligence Manager (Clinical Data Standards) United States
Skills & Focus: regulatory, clinical data, submissions, data management, biostatistics, programming, compliance, SDTM, ADaM, GCP
About the Company: Johnson & Johnson is a healthcare company dedicated to innovating solutions and improving health for humanity.
Experience: At least 6 years of relevant pharmaceutical/scientific experience
Type: Hybrid
Benefits: Competitive salary and extensive benefits package with a flexible working environment

Immunovant, Inc.

Senior Director, Clinical Quality Assurance (CQA) United States
Skills & Focus: Clinical Quality Assurance, GCP compliance, biopharmaceutical, clinical trials, FDA, EMA, risk mitigation, quality systems, CROs, leadership
About the Company: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn t…
Experience: A minimum of eight (8) years of GCP experience with a focus on quality and a minimum of five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; a minimum of two (2) years managing Phase 1-3 clinical trials.
Salary: $250,000 - $265,000 USD
Type: Full-time
Benefits: Full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Syneos Health

Regulatory Consultant United States
Skills & Focus: regulatory submissions, IND, PMA, NDA, MAA, CTD, compliance, administrative components, project management, scientific advice
About the Company: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We are dedicated to developing our p…
Experience: Moderate pharmaceutical/medical device related experience.
Type: Remote
Sr Regulatory Associate United States
Skills & Focus: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS, regulatory submissions, regulatory compliance, quality control
About the Company: At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. We work hard, and smart, in the name of getting much-needed therap…
Experience: 3-5 years of Regulatory Experience within Industry
Salary: $47,000-$79,900 USD
Benefits: Health benefits including Medical, Dental, Vision, Company match 401k, Employee Stock Purchase Plan, eligibility to ear…

Fitt Talent Partners

Herbalist United States
Skills & Focus: herbal medicine, product development, formulation, regulatory compliance, quality control, cross-functional collaboration, FDA regulations, cGMP, herbal practices, consumer testing
About the Company: Fitt Talent Partners is a specialized recruitment firm for top health and wellness companies.
Experience: 3-5 years in herbal product development and formulation
Type: Full time

Jazz Pharmaceuticals

Senior Manager, Medical Writing United States
Skills & Focus: Medical Writing, clinical regulatory documents, cross functional review process, ICH guidelines, Good Clinical Practices, authoring documents, clinical study protocols, effective communication, project management, regulatory requirements
About the Company: Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to deve…
Experience: At least 6 years (or advanced degree with at least 4 years) writing experience in the pharmaceutical industry across therapeutic areas required.
Salary: $137,600.00 - $206,400.00
Benefits: Medical, dental and vision insurance, 401k retirement, discretionary annual cash bonus or incentive compensation, discr…

Amgen

Senior Associate - Regulatory Affairs United States
Skills & Focus: Regulatory Affairs, FDA, submissions, IND applications, BLA, compliance, document management, regulatory research, GRT, quality check
About the Company: At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all…
Experience: 2 years of regulatory or pharmaceutical experience
Salary: 89,063.00 USD - 109,121.00 USD
Type: Full-time
Benefits: Comprehensive employee benefits package, including a Retirement and Savings Plan, medical, dental and vision coverage, …