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.
Candidate Profile:
- 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:
Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at a.brenner@panda-int.com. 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.