Regulatory Affairs Manager

• End-to-end manufacturing of precision titanium dental components
• Active expansion into regulated international markets (EU priority)
• Vertically integrated production model (design → manufacturing → packaging)
• Focus on enabling high-quality, compliant dental implant solutions globally

• EU MDR Compliance: Lead the end-to-end CE marking process for all Boris products under EU MDR 2017/745. Determine product classification (Class IIa/IIb), select the conformity assessment route, and manage the Notified Body relationship through to certificate issuance.
• Quality Management System: Build and maintain an ISO 13485-certified QMS for the organisation. Coordinate with the Dubai manufacturing team to ensure production processes are documented, validated, and audit-ready.
• Technical Documentation: Prepare and maintain complete technical files per MDR Annex II/III, including risk management (ISO 14971), biocompatibility assessments (ISO 10993), design verification/validation, sterilisation validation, and labelling/IFU.
• Clinical Evaluation: Develop clinical evaluation reports leveraging equivalence data and published literature for established titanium implant components. Identify where clinical investigations may or may not be required.
• Notified Body Management: Select, engage, and manage the Notified Body. Prepare for and lead QMS and technical documentation audits. Serve as the primary point of contact for all regulatory body interactions.
• Post-Market Surveillance: Design and implement PMS plans, periodic safety update reports (PSURs), and vigilance reporting systems per MDR requirements.
• HPRA & Competent Authority Liaison: Manage all interactions with the Irish Health Products Regulatory Authority, including device registrations and EUDAMED submissions.
• Regulatory Strategy: Advise the CEO on classification decisions, claim strategy (keeping claims narrow to reduce evidence burden), and regulatory pathways for new product introductions.
• Future Market Access: Lay groundwork for FDA 510(k) submissions (US market) and MOHAP registration (UAE market) as the company scales.
• Team Building: As the regulatory function grows, recruit and manage additional regulatory/quality staff.

• Degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field

• 4–7 years in medical device regulatory affairs
• Proven experience taking Class IIa/IIb devices through EU MDR from scratch
• Experience building or significantly improving a Quality Management System

• Strong expertise in EU MDR 2017/745
• Working knowledge of ISO 13485, ISO 14971, ISO 10993
• Experience with technical documentation (Annex II/III)
• Understanding of clinical evaluation methodologies
• Strong regulatory writing and submission experience
• Excellent written and verbal English

• Ownership and accountability
• Strategic thinking and decision-making
• High autonomy and self-direction
• Strong attention to detail
• Effective stakeholder and regulatory communication

• This is a foundational, hands-on role (not a maintenance position)
• Hybrid role based in Dublin, Galway, or Limerick
• Full-time, permanent contract

Truly Dental