Regulatory Affairs Manager
For one of our clients, a medical device company specialised in combination and OTC products, we're looking for a Regulatory Affairs Manager to manage a team of 7 Regulatory Specialists.
The RA Manager is responsible for providing strategic Regulatory support to the business. You will be in charge for ensuring compliance for the several products with relevant legislation in the area of Medical Devices in the EU (MDD/MDR, ISO13485 and ISO14971).
- Manage a team of Regulatory Specialists (7FTE)
- Reporting to higher management regarding projects and compliance issues
- Maintain of expertise for the Regulatory team (Training, networking, ...)
- Work in a matrix environment by providing regulatory support to Product Development, Artwork approvals, Advertisement Materials and Support Documentation
- Develop implemenation of strategies and analyze impact assesments of changes in the requirements
- Oversight of daily-base regulatory activities
- Product registrations, certifications and notifications
- Review of MD Technical files in compliance with the MDD/MDR
- Participate in category and product meetings
- Communicatie with the authoritiesm notified bodies and international RA authorities regarding applications and compliance
- MSc. in Life Sciences, Legal or Engineering
- Min 8 years of experience in a Regulatory Position
- Min. 2 years of experience in coaching/managing a team
- Experience in Consumer Health/Self-care products is an asset
- Extensive knowledge of Medical Devices regulations (MDD/MDR)
- Excellent project management and communication skills
- Fluent in English, another language is an asset
- Eligible to work in Belgium
This role provides an option for homework and flexible workhours.