JOB DESCRIPTION
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 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.
The Role
This role will take full ownership of obtaining and maintaining CE marking under EU MDR 2017/745 for a growing portfolio of implantable and accessory medical device components. You will be the single point of accountability for regulatory strategy — from classification through to Notified Body certification and post-market surveillance. This is a build role. You will establish the regulatory and quality infrastructure, select and manage external partners, and ensure products are placed on the European market in full compliance.
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.
Requirements
Essential
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)
For further information please contact James Cassidy [email protected] or call in confience 086 0204322
