About the role
Help improve patient safety wordwide!
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.
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 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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