Post Market Surveillance Specialist for Medical Devices

About This Opportunity

We are representing a confidential medical device organization seeking a Post Market Surveillance Specialist in Berlin. Our client develops advanced surgical technologies used in operating rooms worldwide, and this role plays a critical part in ensuring device safety and regulatory compliance throughout the product lifecycle.

As their recruiting partner, Get A Job.ai is managing the full candidate process. You'll work directly with our talent team, and we'll advocate for you throughout the hiring journey.

Responsibilities

• Evaluate adverse events using clinical information and device investigation results
• Assess regulatory reporting obligations based on international requirements and prepare vigilance reports for regulatory authorities worldwide
• Monitor and evaluate medical device vigilance data from global databases
• Support benefit-risk evaluations and risk assessments to inform safety decisions
• Contribute to Health Risk Assessments and participate in recall and Field Safety Corrective Action (FSCA) evaluations
• Create and maintain recall and FSCA documentation in compliance with regulatory standards
• Support Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities
• Conduct literature reviews and data assessments in accordance with MDR requirements
• Serve as a key contact for vigilance-related questions from internal and external stakeholders
• Communicate with regulatory authorities and customers on safety-related topics
• Contribute to continuous improvement of vigilance processes, SOPs, and compliance systems
• Collaborate across Quality, Regulatory Affairs, Clinical, Risk Management, and Product teams

What We're Looking For

Required:

• Degree in Life Sciences, Natural Sciences, Biomedical Engineering, Healthcare, or 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

Preferred:

• 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

How We Work With You

When you apply through Get A Job.ai, a recruiter from our team will screen your qualifications and discuss the role in detail. If there's a strong match, we'll submit your profile to our client and guide you through their interview process. Please do not contact the employer directly—all communication should go through our recruitment team to ensure proper representation.

Pay

Compensation details will be discussed during the screening process with our recruiting team.

Equal Opportunity: Get A Job.ai is committed to inclusive hiring practices and provides equal employment opportunity to all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic.