Head of Regulatory and PRRC for a core product incl. Project Management (m/f/d)

Qualifications

• Passion for working in medical technology development
• Strong sense of ownership, drive, independence, and commitment
• A technical or scientific degree or equivalent training
• Several years of experience in a regulatory position in the medical device sector with broad responsibilities across the regulatory spectrum (i.e., companies with five or less people in regulatory such as startups or SMEs)
• Expertise in regulatory affairs, including liaising with regulatory bodies and developing regulatory strategy
• Project management experience
• Confident acting as the primary point of contact for internal teams and external partners
• Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR
• Preferably, knowledge of standards such as IEC 60601 and IEC 62366
• Strong technical/regulatory writing skills are important
• Hands-on, independent working style suited to a small-team / startup environment
• Negotiation skills, with experience managing partner and vendor relationships
• Proficiency in Microsoft Office and fluent in English, both written and spoken

Select benefits

• Company car
• Public transport ticket (Deutschlandticket Job / JobTicket)
• Urban Sports Club membership
• Flexible, mobile working arrangements and flat hierarchies
• Regular opportunities for training and professional development
• Employee stock option program

We look forward to hearing from you.

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Source: Statistisches Bundesamt (Destatis), table; dl-de/by-2-0; StarIn's calculation