Post Market Surveillance Specialist for Medical Devices

Surgery, we develop innovative technologies that support surgeons around the globe and contribute to better patient outcomes. Our solutions for minimally invasive surgery, including insufflators, pumps, tubing systems, medical visualization, and operating room integration technologies, are trusted by healthcare professionals worldwide. As a Post Market Surveillance Specialist, you will play a critical role in ensuring the safety and performance of our medical devices throughout their lifecycle. Your expertise will directly contribute to protecting patients, supporting regulatory compliance, and driving continuous product improvement. Tasks What makes this role special? Every day, your work helps ensure that medical devices used in operating rooms around the world remain safe, effective, and compliant. You will collaborate with cross-functional teams, evaluate real-world device performance, interact with regulatory authorities, and help shape critical decisions that impact patient safety. If you are passionate about medical devices, risk assessment, and global regulatory compliance, this is an opportunity to make a meaningful difference. Your Responsibilities Ensure Patient Safety & Regulatory ComplianceEvaluate adverse events using clinical information and device investigation resultsAssess regulatory reporting obligations based on international requirementsPrepare and submit vigilance reports to regulatory authorities worldwideMonitor and evaluate medical device vigilance data from global databasesSupport benefit-risk evaluations and risk assessments Drive Post-Market Surveillance Activities Contribute to Health Risk Assessments and safety evaluationsParticipate in recall and Field Safety Corrective Action (FSCA) assessmentsCreate and maintain recall and FSCA documentationSupport Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activitiesConduct 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 stakeholdersCommunicate with regulatory authorities and customers regarding safety-related topicsContribute to the continuous improvement of vigilance processes, SOPs, and compliance systemsWork closely with Quality, Regulatory Affairs, Clinical, Risk Management, and Product teams Required Qualifications Degree in Life Sciences, Natural Sciences, Biomedical Engineering, Healthcare, or a related fieldExperience within the medical device industry or another highly regulated environmentExperience with adverse reporting and regulatory submissionsKnowledge of international vigilance and post-market surveillance requirementsExperience in risk assessment and benefit-risk evaluationStrong analytical and documentation skillsStructured, detail-oriented, and proactive working styleAbility to manage multiple priorities and complex workflowsExcellent English communication skills, both written and verbal Nice to Have Experience with PMS, PMCF, Vigilance, or Medical Device Reporting activitiesKnowledge of MDR, MDSAP, or global regulatory requirementsExperience with literature reviews and regulatory medical writingGerman language skills Benefits What We Offer The opportunity to directly contribute to patient safety and improve healthcare outcomesAn international and collaborative working environmentExposure to global regulatory activities and medical device innovationsCross-functional collaboration with industry expertsProfessional growth and development opportunitiesFlexible working arrangementsCompetitive compensation and benefits package Skills: Quality Management