Establish full ownership of EU MDR Technical Documentation and regulatory dossiers for dermatological hardware and SaMD products in the Skin Program.
Support or lead at least one FDA premarket submission or CE marking activity, demonstrating end-to-end ownership of the submission process.
Become the primary regulatory contact for the Skin Program engineering, clinical, and product teams — embedded in design reviews and change control processes from day one.
Actively contribute to post-market surveillance, PMCF, vigilance, and complaint handling activities, ensuring all products remain in continuous compliance across their lifecycle.

BSc or MSc degree within law, medicine, pharmacy, engineering, or another relevant scientific discipline; or equivalent professional experience.
At least 3 years of professional experience in regulatory affairs or quality management for medical devices.
Working knowledge of EU Regulation 2017/745 (MDR), FDA 21 CFR (including QSR), UK MDR, ISO 13485, ISO 14971, IEC 60601-1 series, IEC 62304, and other applicable standards.
Experience with regulatory submissions and direct communication with authorities and Notified Bodies across international markets.
Excellent analytical skills, able to interpret complex regulatory requirements and provide risk-based, practical recommendations.
Strong writing and communication skills; able to give clear direction to development teams and engage credibly with external stakeholders.
Highly self-motivated; able to manage multiple workstreams independently and with minimal supervision.
Fluent in English (oral and written).

Regulatory Affairs Engineering Lead – Skin Program

Key skills