Dublin, County Dublin, Ireland Company: Bitrecruit Client / Employer: Occupop
Posted: 20.05.2026
Job reference: 4ecd7ac577c93fccca224fde1ca4b259
Who We Are
Boris Manufacturing (trading as Boris Implant Solutions) is a vertically integrated dental implant component manufacturer headquartered in Dubai, with operations in Ireland. The company designs, machines, coats, and packages precision titanium components for the global dental implant market. It is currently building its regulatory function from the ground up to support expansion across Europe and beyond.
Fast Facts
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
Role Purpose
Lead and build the regulatory and quality function from scratch, ensuring successful CE marking under EU MDR and enabling Boris to bring its products to the European market and scale internationally.
Key Responsibilities
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.
Requirements: Skills & Competencies
Education
Degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field
Experience
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
Technical Knowledge & Skills
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
Core Competencies
Ownership and accountability
Strategic thinking and decision‑making
High autonomy and self‑direction
Strong attention to detail
Effective stakeholder and regulatory communication
Important Considerations Before Applying
This is a foundational, hands‑on role (not a maintenance position)
Hybrid role based in Dublin, Galway, or Limerick
Full‑time, permanent contract
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