Provide regulatory guidance throughout the product lifecycle, from development to market launch.
Support development and maintenance of regulatory strategies for cardiological devices and software, covering classification positions, intended use, and market entry sequencing.
Prepare and maintain EU MDR Technical Documentation and other regulatory dossiers.
Support FDA premarket submissions and product registrations in applicable markets.
Assess the regulatory impact of design and process changes and support change control activities.
Contribute to device labelling and traceability activities.
Participate in risk management activities in line with ISO 14971.
Support post-market surveillance, PMCF, vigilance, CAPA, and complaint handling activities.
Contribute to internal and external audits, including Notified Body audits.
Collaborate with engineering, clinical, product, and quality teams on regulatory and compliance matters.

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 – Heart Program

Key skills