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About the Role
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. 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.
Responsibilities
- 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
- 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
- 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
- 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
Skills
- PMS
- PMCF
- Vigilance
- Medical Device Reporting
- MDR
- MDSAP
- Global regulatory requirements
- Literature reviews
- Regulatory medical writing
- German language skills
Education Level
- Degree in Life Sciences, Natural Sciences, Biomedical Engineering, Healthcare, or a related field
Benefits
- 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
About the Company
- At Novanta Advanced 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.