Specialist Vigilance & Post-Market Surveillance (m/f/d)

Do you want to specifically use your experience in medical technology for the safety of medical devices?

Do you combine technical understanding with knowledge of regulatory requirements and quality management?

Are you interested in a role in the area of vigilance and post-market surveillance as well as risk management of medical devices?

Our innovative process is revolutionizing intensive care medicine and saving lives daily. As a dynamically growing medical technology company, we rely on the highest quality and safety standards.

To ensure the continuous monitoring and safety of our products in the market and to excellently fulfill all regulatory requirements, we are looking for a:

Specialist Vigilance & Post-Market Surveillance (m/f/d)

In this position, you will evaluate incidents, process regulatory reporting obligations, and support the monitoring of our products after market launch.

Your Tasks:

• You will evaluate incidents based on the event description and the investigation results concerning the affected medical device and decide on the reporting obligation of incidents based on international regulatory requirements in cooperation with the PRRC.

• You will report incidents according to the respective country-specific requirements.

• You will create documents for post-market surveillance (PMS) and/or post-market clinical follow-up (PMCF) and keep them up-to-date within deadlines.

• Provision of a platform for processing inquiries regarding problems and improvements of the products (e.g., Which conditions lead to error XY).

• You will research and evaluate vigilance data for medical devices in country-specific databases.

• You will coordinate risk analyses and the evaluation of the benefit-risk ratio.

• You will decide on the necessity of recalls and field safety corrective actions (FSCA) based on international regulatory requirements.

• You will create the documentation for recalls and field safety corrective actions.

• You will be the point of contact for authority inquiries and will conduct communication of vigilance cases.

• You will update vigilance-related standard operating procedures (SOPs) based on the MDR, relevant MDCG guidelines, and other international regulatory requirements.

• You will coordinate the necessary follow-up processes for tracking open information and cases.

Work Style: Hybrid working possible with regular presence at the main site in Munich

Your Profile:

• Completed degree in Engineering/Natural Sciences or comparable

• Structured and conscientious way of working, as well as the ability to consistently follow up on open topics and actions

• Very good language skills in German (at least C1) and good English skills (B2)

• Preferably first professional experience in medical technology or a comparably regulated industry, e.g., the pharmaceutical industry.

• Preferably practical experience in quality management according to ISO 13485.

• Preferably knowledge of the EU Medical Device Regulation (MDR), especially Articles 83 to 87

• Preferably knowledge of risk management for medical devices according to ISO 14971

• Preferably experience in other international country-specific regulations for vigilance and product surveillance

We Offer:

• A secure job with purpose and responsibility

• Fair pay and regulated working hours

• A dedicated team that supports you

• Structured onboarding. We guide you step by step

• Central location at the Innovation Campus Munich Technology Center

We look forward to your application! Start whenever you are ready - preferably immediately.

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