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Regulatory Affairs Manager

4 months ago

Sheffield, United Kingdom Airton Solutions Full time

Multi award winning, Northern based manufacturer of Medical Devices has a need for a Regulatory Affairs Manager. Forming part of the Senior Management team, the Regulatory Affairs Manager will provide expert leadership and strategic direction across all facets of Regulatory Affairs, crucially supporting the formulation, development, and implementation of company policies and business objectives. The Role: The leadership and management of a skilled Regulatory Affairs team, tasked with efficiently transitioning MDD technical files to MDR compliance while concurrently facilitating the development of innovative new products. As an integral member of the senior leadership team, the successful candidate will be instrumental in propelling the organisation forward, crafting a robust regulatory strategy that fosters sustained business growth. The Person:

  • Degree educated, or equivalent, in a life science or engineering discipline.
  • Extensive proficiency acquired within a medical device regulatory environment.
  • Comprehensive knowledge and understanding of regulatory requirements governing the placement of medical devices in the European market.
  • Demonstrated ability to effectively lead and influence teams.
  • Currently occupying a managerial role within a Regulatory Function or a Senior/Lead Regulatory Affairs Specialist poised for advancement into management.
The Opportunity: The organisation is well established with a formidable brand reputation across the markets they serve. As they embark on further expansion into the UK, European, and Global arenas, exciting business challenges await, including the reshaping and refinement of corporate culture, as well as the establishment of new teams and partnerships. This role presents a unique opportunity to nurture and develop our newly formed Regulatory Affairs team, actively contributing to the realisation of the company’s strategic growth objectives. How to Apply: If you possess the requisite background and expertise and are eager to make a meaningful impact within our clients organisation, we invite you to submit your CV. Upon review, we will reach out to schedule an exploratory conversation. About Us: Airton Solutions is a reputable brand in the manufacturing and engineering sector, headquartered in Leeds. With a global reach, we are committed to providing unparalleled levels of knowledge and customer service to both clients and candidates. Upholding a policy of equal opportunities, we ensure fairness and inclusivity in all aspects of our operations, regardless of age, gender, marital status, sexual orientation, race, ethnic origin, religion, color, or disability