Head of Regulatory Affairs
Company: iO Associates Agency
- Location: Cologne, Germany
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
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 strateg
- yWriting technical documentation and submissions hands-o
- nLeading registration and market launch of the core produc
- tMaintaining compliance with ISO 13485 and 21 CFR 82
- 0Managing the regulatory project plan and negotiating with partners and vendor
s
Candidate profil
- e:
Technical or scientific deg
- reeSeveral years in medical device regulatory affa
- irsProven end-to-end ownership of a submission, from strategy to appro
- valStrong regulatory writing skills: you still write the documents yours
- elfExperience in an SME or start-up with broad responsibility, rather than only managing teams in a large corpor
- ateSolid knowledge of MDR, ISO 13485, ISO 14971 and 21 CFR
- 820IEC 60601 and IEC 62366 knowledge is a p
- lusFluent English (German not requir
ed)
The pack
- age:
€80,000 - €125,000 base s
- alaryEmployee stock option prog
- rammeOption for a compan
- y carPublic transport t
- icket30 days' annual
- leaveHybrid 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 appl
y 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 con
tract.
