Outstanding opportunity to join a specialist medical product distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance with relevant operating standards. With the support of a QA team, you will lead a cultural change programme to embed best practice across the organisation. This role is offered on a hybrid working basis with 3 days on site per week.
Responsibilities
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. This is a rare opportunity in the current market with a clear career progression path to the board. There is a comprehensive profit share bonus scheme and enhanced benefits package. Full job description available on request. Apply today for immediate consideration! Job Details
Seniority level:
Director Employment type:
Full-time Job function:
Distribution, Quality Assurance, and Science Industries:
Chemical Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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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. This is a rare opportunity in the current market with a clear career progression path to the board. There is a comprehensive profit share bonus scheme and enhanced benefits package. Full job description available on request. Apply today for immediate consideration! Job Details
Seniority level:
Director Employment type:
Full-time Job function:
Distribution, Quality Assurance, and Science Industries:
Chemical Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
#J-18808-Ljbffr
