Post Market Surveillance Specialist for Medical Devices

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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