Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs - Medical Device

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Summary

The Senior Manager, Regulatory Affairs - Medical Device leads operational activities within Medical Device Services (MDS), requiring strong professional experience, scientific expertise, and sector knowledge across medical technology and veterinary products. Medical advice experience and skills are essential.

The Role

This is a senior individual contributor role focused on project leadership, client support, and specialist regulatory expertise, working closely with clients, colleagues, and Health Authorities.

Primary Duties and Responsibilities

• Lead the planning and execution of client projects in line with KPIs, timelines, budgets, and quality standards.
• Coordinate project teams, including internal colleagues and qualified external partners.
• Provide expert consultancy and practical guidance to clients and colleagues on Medical Device Services matters.
• Participate in regulatory, technical, and quality management activities for medical device and diagnostics clients.
• Prepare, review, and compile project documentation within MDS assignments.
• Communicate effectively with clients and Health Authorities.
• Support scientific advice procedures and represent clients with Health Authorities.
• Build and maintain strong client relationships and identify opportunities for increased service support.
• Contribute to project staffing proposals and delivery planning.
• Apply and share Medical Device Services intelligence with colleagues.
• Deliver seminars, presentations, and lectures for colleagues, clients, and professional audiences.
• Support VDC strategy implementation and continuous optimization.
• Comply with internal processes and contribute to their improvement.
• Provide day-to-day operational support to colleagues.
• Support commercial, marketing, and business development activities, including proposal input.
• Oversee project delivery against budget and support resolution of invoicing queries.
• Provide on-site regulatory support to GCS clients where agreed with the Head of VDC REG.
• Undertake other reasonable duties aligned to the role and level of expertise.

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.
• Proven ability to solve complex problems and lead delivery within a specialist environment.
• University degree in Science or Engineering.

Skills and Capabilities

• Translate strategic goals into tactical plans and concrete milestones.
• Define and manage escalation processes appropriately.
• Prioritize effectively and act in line with operational policies.
• Lead complex project activities and provide change management guidance.
• Identify up-selling and cross-selling opportunities.
• Lead project teams and align responsibilities to team strengths.
• Strong relationship management with internal stakeholders and external client department heads.
• Excellent written and verbal communication, with the ability to communicate critical issues clearly to decision-makers.
• Strong presentation skills and business fluency in English and the relevant local language.

What Cencora Offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice.

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.