Qualifications & Experience
- You are responsible for translating regulatory requirements in the field of quality management, conformity assessments and registrations, post-market surveillance, vigilance, and clinical evaluation/investigation, into efficient processes.
- You have a generalist approach when it comes to regulatory operations projects.
- Based on a list of priorities agreed with the business unit, you will work to meet the regulatory requirements to do business: you will analyze the applicable regulations, define product registration strategies and work together with a wide range of teams to generate and review product documentation to ensure a timely market access for our medical solutions.
- You are accountable for the completeness and quality of our CE technical files and submissions, coordinating between the various departments involved writing the documentation.
- You are willing to grow into a professional track, possibly specializing in specific product/market expertise.
- Master level in a medical, engineering or regulatory field.
- A minimum of 3 years of experience in regulatory affairs in the medical device industry.
- You possess practical knowledge of at least one of the regulatory frameworks mentioned above.
- You have a track record in implementing regulations into workable and efficient processes.
- You master good organizational skills with a pragmatic, hands-on and flexible approach to your work.
- You are able to keep a high level overview of ongoing priorities and can easily coordinate multiple projects.
- You are responsible for following up with internal/external stakeholders and are used to work within an international team across various time-zones.
- You are a good communicator, within the company and towards relevant authorities.
- Good written and verbal skills in English is a must, Dutch and/or French is an asset.