Director of Quality & Regulatory Affairs

About the company

Our client is a privately owned, Irish-headquartered diagnostics company that designs, manufactures and sells its own products into more than 30 countries.

• Award-winning, high-growth business with manufacturing and R&D in Ireland and operations internationally.
• Proprietary molecular diagnostic products used widely by clinical laboratories and major hospital networks.
• Portfolio approved under CE-IVDR, FDA and UKCA/MHRA.
• Sustained investment in R&D and a growing new-product pipeline.
• Recognised for a people-first, flexible culture.

Role purpose

The Director of Quality & Regulatory Affairs owns the company's quality system and global regulatory strategy, keeping every product compliant and on market while enabling growth into new products and territories.

This is a senior leadership role in a growing, privately owned business. It suits someone who can set strategy at board level one day and roll up their sleeves on an audit or a technical file the next.

• Reports to: CEO
• Location: Mid-West Ireland, with some travel to international sites and to Notified Body, customer and regulator meetings
• Leads: Quality Assurance, Quality Control and Regulatory Affairs teams across Ireland and international sites
• Member of: Senior Leadership Team

Key responsibilities

Quality leadership

• Own and continuously improve the ISO 13485 quality management system across all company sites, including the IVDR, FDA 21 CFR Part 820 (QMSR) and MDSAP requirements that apply.
• Act as Management Representative and lead Management Review, quality objectives and KPIs.
• Lead Notified Body, FDA, HPRA, MHRA and customer audits from preparation through to closure of findings.
• Oversee CAPA, nonconformance, complaints, internal audit, supplier quality, change control and document control.
• Ensure product release, QC testing and batch record review meet regulatory and customer requirements.
• Build a practical, risk-based quality culture across manufacturing, R&D and commercial teams.

Regulatory affairs

• Set and deliver the global regulatory strategy for the existing portfolio and the new product pipeline.
• Own IVDR technical documentation, performance evaluation and the relationship with the Notified Body.
• Lead FDA submissions (510(k), De Novo) and MHRA/UKCA registrations, plus registrations in other export markets.
• Monitor regulatory change and turn it into clear, timely action plans for the business.
• Ensure labelling, UDI and claims meet the requirements of each market.

Post-market and risk

• Run post-market surveillance, vigilance, field safety corrective actions and trend reporting.
• Own the ISO 14971 risk management process across the product lifecycle.

Product development partnership

• Work alongside R&D on design controls, verification and validation, and clinical performance studies so new assays reach market efficiently.
• Provide regulatory input on product roadmap, market entry and partnership decisions.

People and leadership

• Lead, develop and grow the QA, QC and RA teams, including succession planning.
• Manage the function's budget and resources.
• Contribute to company strategy as a member of the Senior Leadership Team.

Experience and qualifications

Essential

• Degree in Science, Engineering or a related discipline (Microbiology, Biochemistry or Molecular Biology an advantage).
• 12+ years in Quality and/or Regulatory within medical devices or IVD, with at least 5 years leading teams at Head of or Senior Manager level.
• Hands-on IVDR experience, ideally having led a Notified Body certification or legacy IVDD-to-IVDR transition.
• Strong working knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820 and international registration requirements.
• Track record of leading Notified Body and FDA inspections with successful outcomes.
• Credible leader who can influence at board level and build trust on the shop floor.

Desirable

• Direct IVD or molecular diagnostics (PCR) experience.
• FDA 510(k) or De Novo submissions led personally.
• MDSAP experience.
• ISO 13485 Lead Auditor qualification.
• Experience in an SME, scale-up or founder-led business where you built systems rather than inherited them.
• Postgraduate qualification in Regulatory Affairs, Quality or a related field.

Personal attributes

• Pragmatic and commercially aware: sees compliance as an enabler of growth, not a blocker.
• Straight-talking and confident enough to challenge, with sound judgement on risk.
• Collaborative, visible and hands-on; comfortable in a close-knit, values-driven culture.