Post Market Surveillance Specialist for Medical Devices

• Ensure Patient Safety & Regulatory Compliance
• Evaluate adverse events using clinical information and device investigation results
• Assess regulatory reporting obligations based on international requirements
• Prepare and submit vigilance reports to regulatory authorities worldwide
• Monitor and evaluate medical device vigilance data from global databases
• Support benefit-risk evaluations and risk assessments

Drive Post-Market Surveillance Activities

• Contribute to Health Risk Assessments and safety evaluations
• Participate in recall and Field Safety Corrective Action (FSCA) assessments
• Create and maintain recall and FSCA documentation
• Support Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities
• Conduct literature reviews and data assessments in accordance with MDR requirements

Collaborate Across Functions

• Act as a key contact for vigilance-related questions from internal and external stakeholders
• Communicate with regulatory authorities and customers regarding safety-related topics
• Contribute to the continuous improvement of vigilance processes, SOPs, and compliance systems
• Work closely with Quality, Regulatory Affairs, Clinical, Risk Management, and Product teams

Requirements

Required Qualifications

• Degree in Life Sciences, Natural Sciences, Biomedical Engineering, Healthcare, or a related field
• Experience within the medical device industry or another highly regulated environment
• Experience with adverse event reporting and regulatory submissions
• Knowledge of international vigilance and post-market surveillance requirements
• Experience in risk assessment and benefit-risk evaluation
• Strong analytical and documentation skills
• Structured, detail-oriented, and proactive working style
• Ability to manage multiple priorities and complex workflows
• Excellent English communication skills, both written and verbal

Nice to Have

• Experience with PMS, PMCF, Vigilance, or Medical Device Reporting activities
• Knowledge of MDR, MDSAP, or global regulatory requirements
• Experience with literature reviews and regulatory medical writing
• German language skills

Benefits

What We Offer

• The opportunity to directly contribute to patient safety and improve healthcare outcomes
• An international and collaborative working environment
• Exposure to global regulatory activities and medical device innovations
• Cross-functional collaboration with industry experts
• Professional growth and development opportunities
• Flexible working arrangements
• Competitive compensation and benefits package

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Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung

Veröffentlicht am 01. Nov. 2026

Veröffentlicht am 01. Nov. 2026