10 Quality Engineering jobs in Bucharest.

Hiring now: Pharmacovigilance Spec @ Ergomed, Regulatory Affairs Mgr Cm @ Parexel, Final Reviewer Certificat @ Sgs, Program Quality Leader @ Segulatech, Pv Officer @ Primevigil, Medical Devices Adverse E @ Baxter.Explore more at jobswithgpt.com.

🔥 Skills

Regulatory Affairs (4) CMC (3) Technical Documentation (3) Project Management (3) Collaboration (3) regulatory compliance (2) Submission Strategies (2) Final Reviewer (2) compliance (2) QMS (2)

đź“Ť Locations

Bucharest (10)
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Ergomed

Pharmacovigilance Specialist Bucharest
Skills & Focus: ICSRs, SAEs, Pharmacovigilance, safety assessment, risk management, signal detection, benefit-risk assessment, literature screening, regulatory compliance, medical evaluation

Parexel

Regulatory Affairs Manager - CMC biologics Bucharest
Skills & Focus: Regulatory Affairs, CMC, Life Sciences, Biopharmaceuticals, Quality Assurance, Submission Strategies, Technical Documentation, Project Management, Risk Mitigation, Collaboration
About the Company: Parexel is a global biopharmaceutical services organization that provides expertise and solutions to companies in the life sciences sector, helping them to nav…
Experience: Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
Type: Remote
Benefits: Flexible work arrangements, opportunities for career growth, and a supportive work environment.

Sgs

Final Reviewer & Certification Decision Maker Bucharest
Skills & Focus: Final Reviewer, Certification Decision Maker, audit packs, compliance, MDD 93/42 EC, MDR (EU) 2017/745, QMS, ISO 13485, technical documentation assessment, regulatory compliance

Segulatechnologies

Program Quality Leader Bucharest
Skills & Focus: Quality objectives, Quality management plan, Risk assessment, FMEA, Process validation, Control plans, Conformity, Traceability, Production Part Approval, Customer Program Quality

Primevigilance

PV Officer Bucharest
Skills & Focus: case processing, Individual Case Safety Reports, post-marketing, clinical trials, SAE Management, SUSAR Management, database outputs, periodic reporting, mentoring, training
About the Company: PrimeVigilance is a team focused on providing independent case processing services in the pharmaceutical industry, working across various sizes of projects inc…
Experience: Several years in case processing

Parexel

Regulatory Affairs Manager - CMC biologics Bucharest
Skills & Focus: Regulatory Affairs, CMC, Biologics, Pharmaceuticals, Submission Strategies, Quality Control, Risk Management, Project Management, Technical Documentation, Collaboration
About the Company: Parexel is a global biopharmaceutical services company that helps clients navigate the complex and ever-changing regulatory landscape.
Experience: Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
Type: Remote/Office-based
Senior Regulatory Affairs Associate - Labelling & Artwork Bucharest
Skills & Focus: Regulatory Affairs, Labelling, Artwork, Secondary Packaging, Project Management, Collaboration, Compliance, Stakeholder Liaison, Process Improvement, Training
About the Company: Parexel is a global biopharmaceutical services company that provides a range of services to clients in the pharmaceutical and biotechnology industries, special…
Experience: Few years of experience in a related pharmaceutical industry role
Type: Remote
Benefits: Flexible work arrangements, opportunities for career growth, diverse and global client exposure

Baxter

Medical Devices Adverse Events Reviewer Bucharest
Skills & Focus: medical review, adverse events, safety signaling, stakeholder insight, negotiation skills, strategic planning, complaints monitoring, clinical investigation, data entry, medical device regulations
About the Company: Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, they have pioneered significant me…
Experience: At least 5 years of medical professional experience, including 2 years related clinical, safety, pharmacovigilance or regulatory experience in the medical device industry.
Benefits: Employee Health & Well-Being Benefits, Paid Time Off, Continuing Education/Professional Development, 2 Days a Year to V…

Sgs

Final Reviewer & Certification Decision Maker Bucharest
Skills & Focus: Final Reviewer, Certification, Medical Device, Compliance, Audit, QMS, MDD, MDR, Technical Documentation, Regulatory Compliance
About the Company: SGS is a global leader in inspection, verification, testing and certification services.

Parexel

Regulatory Affairs Manager - CMC biologics Bucharest
Skills & Focus: Regulatory Affairs, CMC, biologics, clinical research, compliance, pharmaceuticals, project management, documentation, FDA regulations, biopharmaceuticals
About the Company: Parexel is a global biopharmaceutical services organization that provides comprehensive drug development and regulatory consulting services.
Type: Full-time