The Senior Regulatory Affairs & Quality Assurance Manager is responsible for leading the company regulatory and quality professionals to support RAQA activities for a lifesaving electronic medical device. The role reports to an off site international Director in the company. The role involves:

• Leading a team of regulatory and quality professionals to deliver against go to market business strategies for the product portfolio
• Monitor, track and actively assess evolving regulations, guidance, warning letters and regulatory policies
• Interpret and apply governmental regulations, agency guidelines, and internal procedures to assure compliance, and assist the organisation in driving implementation
• Develop organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory and quality processes
• Serve as the PRRC with overall responsibility for conformity of devices, maintenance of technical documentation and post market obligations
• You may also hold the position of Management representative deputy regarding quality and regulatory related issues
• Direct all regulatory activities to ensure new product development and product sustainment meet regulatory requirements and customer quality expectations
• Establish annual budgets and quarterly forecasts
• Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
• Represent regulatory and quality processes during internal and external audits
• Recruit, select, and on-board top talent and maintain a high level of team engagement
• Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature

Essential criteria for the role:

• Minimum of 6+ years experience in a similar Regulatory Affairs role at a senior lead level
• Minimum of 4+ years in a people management role
• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
• Science, engineering or related degree
• Demonstrate technical knowledge of medical device product lines
• Demonstrated experience with trending and analysis

If this role is of interest; or if you have a relatable skillset that might match other similar vacancies; then please send an updated CV via the link on the page, or get in touch with Hugh Nugent to discuss in absolute confidence

Hugh has 12 years' experience specifically in Engineering / Manufacturing Recruitment and specialises across Senior Executive Placements, Design/Development and Quality Engineering roles throughout Northern Ireland.

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This role would be particularly suitable for those from the Belfast, Antrim, Bangor, Lisburn, Portadown, Craigavon, Lurgan, Larne, Banbridge, Carrickfergus, Armagh areas.