Vigilance Specialist
A globally recognized manufacturer in the medical device industry is looking to strengthen its Post‑Market Surveillance & Vigilance function. The company develops advanced technologies used across intensive care, emergency transport, and other critical healthcare environments, supporting a wide range of clinical applications.
How you will contribute:
- Conduct reportability assessments for incoming post‑market events
- Prepare initial vigilance reports within required timelines
- Take responsibility for meeting deadlines and complying with regulatory timeframes
- Create final reports based on completed investigations
- Communicate effectively with internal teams and external partners
- Manage communication with health authorities, including cases of higher complexity
- Prepare overviews and summaries of reported events for regulatory bodies
- Generate statistics for the annual management review
- Participate in audits and inspections as needed
- Assist in process improvement projects across the PMS/Quality areas
- Support and coach team members in their daily tasks
What you bring:
- Strong experience in Post‑Market Surveillance, specifically in vigilance reporting (assessment, initial reporting, follow‑up, final reporting)
- Ability to communicate confidently with competent authorities
- A critical mindset with the ability to challenge data quality and ensure data integrity
- Familiarity with complaint handling, CAPA, and related quality system processes
- Solid knowledge of medical device regulations (EU‑MDR 2017/745, FDA 21 CFR 803, MDSAP)
- Fluency in English and German
- Strong communication and problem‑solving skills
- A structured, detail‑oriented approach to documentation
- Curiosity, willingness to learn, and a proactive attitude
- Ability to prioritize effectively and work within defined timelines
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.