Are you a detail-oriented regulatory professional ready to ensure innovative implantable devices meet the highest global standards?
Would you like to be part of a pioneering team establishing a brand-new manufacturing facility for critical medical technology?
Join our client’s growing Regulatory Affairs team and play a key role in guiding breakthrough active implantable medical devices through certification and approval processes in Europe and beyond.
Support the design and development of new products in regulatory terms, ensuring compliance with MDR and FDA requirements.
Provide regulatory input on design changes to existing products.
Prepare and maintain regulatory documentation, including device files and MDF submissions.
Lead and guide medical device certification processes, including CE marking and future FDA approvals.
Ensure compliance with ISO 13485, MDR, FDA, and other relevant regulatory standards for Design & Development.
Contribute to Post-Market Surveillance (PMS) activities.
Perform regulatory assessments and provide guidance on new business development opportunities.
Act as a partner to cross-functional teams, supporting Quality, R&D, and Production in achieving regulatory compliance.
Bachelor’s or Master’s degree in a scientific, technical, or regulatory field.
3+ years of experience in Regulatory Affairs within the medical device industry.
Strong knowledge of MDR; experience with FDA submissions is a plus.
Proven track record in CE certification processes and regulatory submissions.
Familiarity with ISO 13485 and other relevant standards for Design & Development.
Experience with Post-Market Surveillance activities.
Excellent communication, documentation, and cross-functional collaboration skills.
Strong command of English (C1); Dutch or French is an advantage.
Join a high-impact team at the forefront of medical innovation.
Take ownership in regulatory processes that directly enable the launch of life-changing implantable technologies.
Be part of a ground-up project with visibility across the organization.
Work in a dynamic, collaborative environment with long-term growth opportunities.
Competitive salary and benefits package.