Senior Manager, Regulatory Affairs - Medical Device

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.

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What You'll Have:

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.
• Ability to prioritize effectively and take action in line with operational policies and project requirements.
• Experience leading complex project activities and providing guidance related to change management.
• Ability to proactively identify up-selling and cross-selling opportunities.
• Strong capability to identify, document, and help drive resolution of project and program issues.
• Ability to lead project teams, coordinate work effectively, and align responsibilities to team strengths.
• Strong relationship management skills with internal stakeholders and external clients, including engagement with client department heads.
• Ability to align on mid-term goals and support the development of long-term client partnerships.
• Excellent written and verbal communication skills.
• Proven ability to communicate critical issues clearly and recommend appropriate cross-functional solutions to decision-makers.
• Strong presentation skills and a confident, professional presence.
• Business fluency in English and the relevant local language.

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned