Director of Quality & Regulatory Affairs Mid-West Ireland | Confidential Executive Search 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 certified under the EU IVDR, with a strong focus on European markets.
• 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, in line with the EU IVDR (2017/746).
• Act as Management Representative and lead Management Review, quality objectives and KPIs.
• Lead Notified Body (TÜV SÜD), HPRA 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 IVDR submissions and conformity assessments with TÜV SÜD, the company's Notified Body, for new and changed products.
• 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 and the EU IVDR, including performance evaluation and post-market requirements.
• Track record of leading Notified Body audits 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.
• IVDR submissions for Class B, C or D devices led personally.
• Experience working with TÜV SÜD or another IVDR Notified Body.
• 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.

For further information on this Director of Quality & Regulatory Affairs role in Limerick please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie. Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/.

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA based on standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

JOB DESCRIPTION

Galway Office Unit 39D, Briarhill Business Park, Briarhill, Galway, Ireland Ph +353 91 730022 Cork Office Penrose House, Penrose Quay, Cork, Ireland Ph +353 21 206 6287 Dublin Office 6 - 9 Trinity Street, Dublin, Ireland, D02 EY47 Ph +353 1 619 0279

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