Head of Regulatory Affairs

Head of Regulatory Affairs (m/f/d)
Köln, Germany | Hybrid (1 day per week on site) | €80,000 to €125,000 Basic Salary + Stock Options

Our client is a venture-backed MedTech start-up developing a complex medical device that addresses a major unmet clinical need. Development is well advanced, and the first technical file submission is coming up. They now need a hands-on regulatory leader to take the product through approval in Europe and the US.

This is a very exciting project for regulatory professionals: it’s one device with multiple indications for use, and you would own the full pathway from strategy to market entry on both sides of the Atlantic.

The Role
You will define the regulatory strategy for EU and US market entry, then carry it out. That means writing the submissions yourself, not just managing others who do. You will be the company’s PRRC and the main regulatory contact for internal teams, notified bodies, the FDA and external partners.

Day-to-day responsibilities:

• Building and executing the EU (MDR) and US (FDA) regulatory strategy
• Writing technical documentation and submissions hands-on
• Leading registration and market launch of the core product
• Maintaining compliance with ISO 13485 and 21 CFR 820
• Managing the regulatory project plan and negotiating with partners and vendors

Candidate profile:

• Technical or scientific degree
• Several years in medical device regulatory affairs
• Proven end-to-end ownership of a submission, from strategy to approval
• Strong regulatory writing skills: you still write the documents yourself
• Experience in an SME or start-up with broad responsibility, rather than only managing teams in a large corporate
• Solid knowledge of MDR, ISO 13485, ISO 14971 and 21 CFR 820
• IEC 60601 and IEC 62366 knowledge is a plus
• Fluent English (German not required)

The package:

• €80,000 – €125,000 base salary
• Employee stock option programme
• Option for a company car
• Public transport ticket
• 30 days’ annual leave
• Hybrid working with one office day per week

If you have taken a medical device through regulatory approval yourself and want to do it again with real ownership, please apply now!

Disclaimer: Any remuneration stated in this advertisement is indicative and will be dependent on the successful candidate’s experience, skills and qualifications. Final remuneration will be agreed with the successful candidate and will be subject to the terms of the contract.