Head of Regulatory Affairs & Projects

Location: Hybrid - 1 day per week on-site in Aachen, Germany.
Salary: 80.000€ to 120.000€ per annum DOE + Equity.

Are you passionate about ethical medical technology development? Our exciting start-up client are developing a groundbreaking and unique medical device that would increase the availability of life-saving surgery for millions of people every year.

They are seeking a Head of RA and Projects to lead regulatory affairs and market introduction. You will be joining a small but highly experienced team of leading experts in the medical device sector.

Key Responsibilities:

Development and implementation of the regulatory strategy.
Serving as the primary regulatory contact for both internal teams and external partners.
Spearhead the registration and market introduction of our flagship product.
Preparation of technical documentation/RA dossiers, working closely with internal and external teams. Initially taking a hands-on approach to writing regulatory documents.
Ensure compliance with quality management standards, including ISO 13485 and 21 CFR 820.

What We're Looking For:

Passionate about ethical medical device development.
Several years of professional experience in the medical device sector, leading regulatory affairs, including interactions with regulatory bodies.
Experienced with ISO 13485, ISO 14971, 21 CFR 820, and MDR.
Business fluent in English. German language is desirable but not essential.