For our medical devices client in Utrecht we are seeking a Regulatory Affairs Specialist to join their rapidly growing team. This role is ideal for someone with a pioneering mindset and experience in navigating regulatory landscapes in the medical device sector.
Role and Responsibilities:
- Develop RA strategies innovative medical devices.
- Establish a post-market surveillance strategy
- Collaborate effectively with technical teams.
- Conduct post-market follow-up activities, ensuring regulatory compliance across various regions.
- Interpret regulations and translate them into actionable insights for device development.
- Minimum of 5 years of experience in Regulatory Affairs for medical devices, backed by a BSc in a technical field.
- Proven track record in bringing innovative MedTech products to market and obtaining regulatory approvals (including CE and preferably FDA).
- Strong knowledge of MDR and various standards such as ISO 14971, IEC 62366, ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 62304.
- Excellent written and verbal communication skills in English, particularly in regulatory writing.
- A confident communicator with a positive, resilient mindset.
- Ability to work collaboratively on challenging tasks and find innovative solutions.
What We Offer:
- Competitive salary with a pension plan.
- Hybrid work model and a dynamic work environment.
- Team activities, stock options, training budget, and opportunities for professional growth.
- A unique chance to be a key player in shaping a new niche in autonomous medical robotics.
This opportunity is perfect for individuals looking to make a significant impact in a scale-up environment within the MedTech industry, working on groundbreaking medical device technology in an open and collaborative culture.
Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at firstname.lastname@example.org. This is an excellent opportunity to join a leading pharmaceutical company in a vital role, so act fast to secure your chance for an interview.