Qualifications & Experience
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. Your focus will be EU and Rest Of World non-US.
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.
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.
- You have a master level in a medical, engineering or regulatory field.
- You have 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.
- You have excellent written and verbal skills in English, Dutch and/or French is an asset.