Senior Manager, Regulatory Affairs

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Job Details

Senior Manager, Regulatory Affairs - Medical Device

Summary

The Senior Manager, Regulatory Affairs - Medical Device is responsible for the execution and leadership of operational activities within Regulatory Development Strategy (RDS). This role requires strong professional experience, scientific expertise, and sector knowledge across drug-device combination products and medical devices.

The successful candidate will lead project delivery, support clients with regulatory and technical matters, contribute to team capability, and help drive business growth and operational excellence. Medical device experience and skills are essential for success in this position.

The Role

As Senior Manager, Regulatory Affairs - Medical Device, you will play a key role in delivering regulatory and scientific support across a range of client projects in the medical device, diagnostics, and drug-device combination product sectors.

This is a senior individual contributor role focused on project leadership, client support, and specialist regulatory expertise. You will work closely with clients, colleagues, and Health Authorities, providing strategic and operational input across medical device related activities. You will also support business development, contribute to internal capability building, and help ensure projects are delivered to high quality, on time, and within budget.

Primary Duties And Responsibilities

• Lead the planning and execution of client projects in line with agreed KPIs, timelines, budgets, and quality standards.
• Coordinate project teams, including internal colleagues and qualified external partners, to ensure effective delivery.
• Provide expert consultancy and practical guidance to clients and colleagues on medical device or drug-device combination product matters.
• Participate in regulatory, technical, and quality management activities for clients in the medical device and diagnostics sectors.
• Prepare, review, and compile project documentation within the framework of assignments.
• Communicate effectively with clients and Health Authorities.
• Support various regulatory procedures and represent clients in interactions with Health Authorities.
• Build and maintain strong client relationships and identify opportunities for increased service support.
• Contribute knowledge and insight to support project staffing proposals and delivery planning.
• Develop and maintain strong awareness of medical device intelligence, applying current knowledge to client projects and actively sharing insights with colleagues.
• Deliver seminars, presentations, and lectures for colleagues, clients, and professional audiences.
• Actively contribute to the sharing of department expertise and best practices.
• Support business group strategy implementation and continuous optimization through personal leadership and collaboration.
• Comply with internal processes and contribute to their ongoing improvement.
• Provide day-to-day operational support to colleagues where needed.
• Support commercial, marketing, and business development activities, including proposal input.
• Oversee project delivery against budget and support the resolution of invoicing queries.
• Provide on-site regulatory support to GCS clients where agreed with the Head of REG.
• Undertake other reasonable duties aligned to the role and level of expertise, as agreed with the Line Manager, Practice Area Lead, or Head of REG.

Experience and Education

• Proven, in-depth professional experience in regulatory affairs, medical device services, or a related specialist field.
• Strong expertise in medical technology and veterinary products.
• Demonstrated experience supporting medical advice activities, with medical advice experience and skills essential.
• Extensive knowledge of the discipline and strong understanding of business and client needs.
• Proven ability to solve complex problems and lead delivery within a specialist environment.
• University degree in Science or Engineering.

Skills And Capabilities

• Ability to translate strategic customer, partnership, or internal project goals into tactical plans and concrete milestones.
• Strong ability to define and manage escalation processes appropriately.
• Structured, analytical, systematic, and independent approach to work.
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