- Full responsibility for all Regulatory Affairs matters across the business, ensuring compliance to ISO13485 and ISO11135
- Develop and plan multiple and extremely complex regulatory affairs projects and activities within program(s) including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables
- Identify and evaluate complex and/or advanced regulatory affairs process improvements and/or course correction/alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
- Responsible for full execution of strategy and contingency plans for projects. Determine strategy, impact and synergies across the RA organization
- Serve in an advisory role to management to provide direction and guidance
- Interact with regulatory authorities for significant projects and may provide on-site audit oversight
- Frequently anticipate and advise on future regulatory trends and direction, and industry best practices, and lead the implementation of preemptive approaches for company regulatory compliance
Back to searchHead of Regulatory Affairs
Pure Resourcing Solutions
Posted 9 hours ago, valid for 21 days
Bury St. Edmunds, Suffolk IP28 6LD
£48,000 - £57,600 per annum
Full Time
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Sonic Summary
- An outstanding opportunity exists for a Head of Regulatory Affairs in a specialist medical product distribution business, reporting directly to the CEO.
- The role requires a minimum of 7 years of experience in regulatory affairs, with a salary range of £80,000 to £100,000.
- Key responsibilities include ensuring compliance with ISO13485 and ISO11135, leading regulatory projects, and implementing process improvements.
- The position offers hybrid working, requiring 3 days on-site per week, and includes a profit share bonus scheme and enhanced benefits.
- This role promises a clear career progression path to the board, making it a rare opportunity in the current market.
