About the Role
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year.
Are you an experienced Quality or Regulatory leader with deep expertise in meeting the requirements of EU MDR and/or IVDR as a Legal Manufacturer? Looking to play a meaningful role in ensuring regulatory compliance throughout Europe, Switzerland, and the UK?
We are seeking a Senior Quality Manager to come and join us at our offices in Limerick or Wexford. In this highly visible role, you will serve as the senior Quality leader for our European Authorized Representative (AR), Swiss Authorized Representative (CH-REP), and UK Responsible Person (UKRP) operations. You will lead all aspects of regulatory compliance activities for manufacturers outside the European Union.
In the role of Person Responsible for Regulatory Compliance (PRRC), you will ensure compliance with EU IVDR, EU MDR, Swiss IvDO, and UK MDR requirements while acting as a key interface between represented manufacturers, Proficient Authorities, Notified Bodies, and internal collaborators.
This role is vital for maintaining market access in Europe, Switzerland, and the UK. It supports post-market surveillance and vigilance. It also helps fulfill economic operators' responsibilities and strengthens our regulatory and quality infrastructure.
Main Responsibilities Will Include
•Act as the designated PRRC supporting EU AR, Swiss CH-REP, and UKRP activities, ensuring compliance with regulatory requirements.
•Verify that technical documentation, declarations of conformity, certifications, registrations, and regulatory records are maintained and up to date.
•Be responsible for economic operator obligations, including UDI, EUDAMED, and other applicable market registration requirements.
•Provide quality and regulatory oversight for post-market monitoring, safety reporting, complaint handling, and field safety corrective actions.
•Serve as the primary liaison in interactions involving Authorities with proficiency such as MHRA, Swissmedic, and Advised Bodies throughout assessments, verifications, and compliance investigations.
•Support the maintenance, continuous improvement, and enhancement of the Quality Management System (QMS) to improve efficiency, including audits, CAPAs, and management reviews.
•Partner with cross-functional teams to ensure regulatory compliance is maintained throughout the product lifecycle and across all represented manufacturers.
Skills and Experience Required
•Bachelor's degree in Engineering, Science, Law, a field related to Regulatory Affairs, or equivalent experience
•Demonstrable experience working directly for an organization acknowledged as a Legal Manufacturer operating under EU MDR and/or EU IVDR
•Expert-level knowledge of ISO 13485 and the European medical device regulations is required
•Experience in Medical Device Regulation and/or the In Vitro Diagnostic Regulation, acquired within a regulatory manufacturing environment
•Strong understanding of Economic Operator requirements, EUDAMED, UK MDR, Swiss medical device ordinance (IvDO), post-market surveillance, vigilance, and PRRC obligations is essential
•Proven experience in Quality Systems, Quality Engineering, in the field of Regulatory Affairs or related functions within the Medical Device, IVD, or Pharmaceutical industries
•Experience of regulatory or QMS experience related to IVD products
•Experience supporting regulatory inspections, audits, and interactions with Proficient Authorities, MHRA, Swissmedic, and/or Notified Bodies preferred
•Experience leading QMS standardization, site consolidations, or operating model transformations is desirable
•Regulatory inspection and audit readiness expertise
•Strong project management, problem-solving, and decision-making skills
•Strategic approach with the ability to translate regulatory requirements into practical business solutions
Why Join Us?
This is an outstanding opportunity to take ownership of a critical compliance function that directly supports international market access and patient safety. You'll work closely with senior regulatory, quality, and business leaders and play a key role in maintaining a robust and compliant regulatory framework across multiple regions.
Location: Limerick or Wexford, Ireland
Working Pattern: 4 days per week on-site
Note: This role will regularly collaborate with teams based in the United States; therefore, flexibility is required to accommodate meetings and activities across different time zones when needed.
Primary Work Location: IRL Limerick - Castletroy
Additional Locations: IRL Wexford - Enniscorthy
Salary Range: €95,200.00 - €145,150.00 EUR Annual
