Regulatory Affairs Manager- Remote

Regulatory Affairs Manager - Medical Devices

Location: Ireland (Remote)

Reports To: CEO / Founder

Employment: Full-time, Permanent

Start Date: ASAP

About the Company

The company is a vertically integrated manufacturer of precision medical device components with international operations. It designs, machines, coats, and packages high-specification titanium components for the global medical device market.

The Organisation

The organisation is building its regulatory function from the ground up. This is a foundational hire where you will own the entire regulatory and quality compliance workstream and shape how products are brought to market across Europe and beyond.

Key Responsibilities

• EU MDR Compliance: Lead end-to-end CE marking under EU MDR 2017/745. Determine classification (Class IIa/IIb), define conformity assessment routes, and manage Notified Body engagement through certification.
• Quality Management System: Build and maintain an ISO 13485-certified QMS. Ensure manufacturing processes are documented, validated, and audit-ready across international operations.
• Technical Documentation: Prepare and maintain technical files per MDR Annex II/III, including risk management (ISO 14971), biocompatibility (ISO 10993), design verification/validation, sterilisation validation, and labelling/IFU.
• Clinical Evaluation: Develop clinical evaluation reports using equivalence data and published literature. Assess requirements for clinical investigations.
• Notified Body Management: Select, engage, and manage the Notified Body. Lead audits and act as primary contact for regulatory interactions.
• Post-Market Surveillance: Implement PMS systems, PSURs, and vigilance reporting in line with MDR requirements.
• Competent Authority Liaison: Manage interactions with relevant European competent authorities, including registrations and EUDAMED submissions.
• Regulatory Strategy: Advise leadership on classification, claims strategy, and regulatory pathways for new product introductions.
• Future Market Access: Support preparation for FDA 510(k) and other international regulatory pathways.
• Team Building: Recruit and develop regulatory and quality personnel as the function grows.

Essential Requirements

• 4-7 years' experience in medical device regulatory affairs under EU MDR 2017/745
• Proven experience taking at least one Class IIa or IIb device through MDR from scratch
• Strong knowledge of ISO 13485, ISO 14971, ISO 10993, and MDR Annex II/III/IX
• Experience building or significantly upgrading a QMS
• Solid understanding of clinical evaluation and equivalence approaches
• Excellent written English (technical documentation and submissions)
• Ability to work autonomously in a fast-paced, high-growth environment

Highly Desirable

• Experience with implantable, orthopaedic, trauma, or surgical devices
• Experience working with non-EU manufacturing and EU market access models
• Familiarity with Irish and broader EU regulatory frameworks
• Knowledge of surface coatings (e.g., PVD) for implantable devices
• Exposure to FDA 510(k) pathways
• Experience with EUDAMED and UDI systems

Nice to Have

• RAC (Regulatory Affairs Certification) or equivalent
• Experience working with or within a Notified Body
• Knowledge of sterilisation validation (EtO, gamma)

Contact

Please contact James Cassidy at or call for further information.