Head of Regulatory Affairs & Projects

Location: Hybrid - 1 day per week on-site in Cologne, Germany.
Salary: 80.000€ to 100.000€ per annum DOE + Equity.

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

They are seeking a Head of RA and Projects to lead regulatory affairs and market introduction for one of their products. You will be joining a small but highly experienced team of leading experts in the field, with decades of experience taking groundbreaking medical devices to market.

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.
Ensure compliance with relevant standards, including ISO 13485, ISO 14971, MDR and 21 CFR 820.

What We're Looking For:

Passionate about ethical medical device development.
Professional experience in the medical device sector in an SME or Start-up.
Broad regulatory affairs experience, including interactions with regulatory bodies.
Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR.
Experience with IEC 60601 and IEC 62366 is highly desirable but not essential.
Business fluent in English. German language is desirable but not essential.