Post Market Surveillance Specialist – Medical Devices

Novanta Inc.

. Evaluate adverse events using clinical information and device investigation results .

Posted 10/19/2026full-timeBerlin • GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in evaluating adverse events and regulatory reporting within the medical device industry, with a strong focus on compliance with international vigilance and post-market surveillance requirements. Proficient in risk assessment, documentation, and effective communication with stakeholders.

Highest-signal resume keywords

Adverse Event ReportingRegulatory SubmissionsPost-Market Surveillance (PMS)Medical Device Reporting (MDR)Risk Assessment

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory ReportingBenefit-Risk EvaluationData AssessmentLiterature ReviewDocumentation SkillsVigilance ProcessesSafety EvaluationsField Safety Corrective Action (FSCA)Post-Market Clinical Follow-Up (PMCF)Compliance Systems

Soft Skills

Analytical SkillsDetail-OrientedProactive Working StyleCommunication SkillsAbility to Manage Multiple Priorities

Industry Keywords

Medical Device IndustryInternational Vigilance RequirementsMDRMDSAPHealthcareLife SciencesNatural SciencesBiomedical EngineeringRegulatory AffairsQuality Management

About the role

Key responsibilities & impact

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

What you’ll need

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
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

Comp & perks

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