We’re Hiring: Senior Manager / Lead, Clinical & Medical Affairs (Medical Devices)
An innovative European medical device company in the aesthetic sector, based in Utrecht, is seeking a Senior Manager / Lead for Clinical & Medical Affairs on a fixed-term/project role (6 months) with an immediate start. This is a fantastic opportunity to contribute to next-generation aesthetic medical devices, including Class III implants and injectables.
Location: Utrecht, NL (hybrid/remote within the EU, with periodic travel to study sites and company HQ)
Company Overview: Their lead product has recently entered its pivotal CE-mark clinical investigation under the EU Medical Device Regulation (MDR).
Role Objective: We are seeking an experienced Clinical & Medical Affairs project leader to lead and coordinate the company’s pivotal CE-mark clinical study and related medical/clinical affairs activities in collaboration with the CRO, clinical experts, and regulatory partners. This senior operational leadership role reports directly to the CEO and involves close collaboration across R&D, Operations, Regulatory, Quality, and Commercial functions.
Key Responsibilities:
- Provide leadership and oversight for the ongoing CE-mark clinical study (Class III implantable).
- Ensure full compliance with MDR and ISO 14155 throughout all phases of the study.
- Manage clinical documentation, submissions, and reporting with the CRO.
- Act as the primary liaison with competent authorities, notified bodies, and clinical experts.
- Refine and implement the company’s clinical and medical affairs strategy.
- Build and manage relationships with external experts, consultants, and key opinion leaders (KOLs).
- Support preparation of clinical evaluation reports and evidence packages for CE marking.
- Provide internal guidance on clinical data interpretation and evidence generation.
Candidate Profile: Education & Experience:
- Advanced degree (MD, PharmD, PhD or equivalent) in Life Sciences.
- 5–10+ years in medical/clinical affairs within medical devices, ideally Class III and/or aesthetic injectables.
- Strong understanding of MDR, ISO 14155, and CE-mark requirements.
- Track record in clinical study management and CRO oversight.
- Experience with regulatory authorities and notified bodies.
Skills & Attributes:
- Strategic mindset with hands-on execution ability.
- Excellent communication and stakeholder management.
- Fluent in English (both written and spoken); French or Dutch are a plus.
- Thrives in a lean, fast-paced, entrepreneurial environment.
Other Requirements:
- Eligible to work in the EU/EEA without visa sponsorship.
Additional Notes:
- This role can be fully remote, with periodic travel to Utrecht and study sites.
- Provides leadership in cutting-edge developments in the medical device industry, focusing on Class III implants and injectables.
- Strong regulatory background and proven experience with CE marking is required.
- French speaking preferred but not mandatory.
Interested? Apply below or send your CV to m.spinetta@panda-int.com