Regulatory Affairs Lead - Medical Devices & Diagnostics

PharmaLex; Greater London; On-site; GBP 90,000 - 120,000; Full time

Job summary

Cencora is recruiting a Senior Manager, Regulatory Affairs - Medical Device to lead regulatory development strategy projects across medical devices and drug-device combinations. You will guide client projects, interact with Health Authorities, and shape regulatory submissions with senior-level input.

The role emphasizes project leadership, regulatory excellence, and business development support, with an expected strong background in medical device regulations and client-facing services.

Qualifications

• 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.

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 external partners, to ensure effective delivery.
• Provide expert consultancy and practical guidance on medical device or drug-device matters.
• Participate in regulatory, technical, and quality management activities for medical device and diagnostics sectors.
• Prepare, review, and compile project documentation within assignments.
• Communicate effectively with clients and Health Authorities.
• Support 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 to support staffing proposals and delivery planning.
• Develop and maintain awareness of medical device intelligence and share insights with colleagues.
• Deliver seminars, presentations, and lectures for colleagues, clients, and professional audiences.
• Contribute to sharing of department expertise and best practices.
• Support business group strategy and continuous optimization through leadership and collaboration.

Skills

Regulatory affairs

Medical devices

Project leadership

Client management

English proficiency

Education

University degree in Science or Engineering

Job description

Cencora is recruiting a Senior Manager, Regulatory Affairs - Medical Device to lead regulatory development strategy projects across medical devices and drug-device combinations. You will guide client projects, interact with Health Authorities, and shape regulatory submissions with senior-level input.

The role emphasizes project leadership, regulatory excellence, and business development support, with an expected strong background in medical device regulations and client-facing services.