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This role is in support of Cencora's global pharma consulting services.
We’re Hiring: Senior Manager, Medical Devices
The Role:
Lead and deliver regulatory/quality client projects for medical devices and diagnostics (IVD), serving as the Subject Matter Expert (SME) for Companion Diagnostics (CDx) and combined/combined studies. Manage senior client relationships, represent clients with Health Authorities, and ensure delivery to KPIs, timelines, and budget. Role is fully dedicated to client delivery (no business development responsibilities).
Key Responsibilities
Act as SME for CDx and combined studies, providing strategic and tactical regulatory guidance across client programs.
Develop and maintain strong client relationships; act as senior point of contact for delivery matters.
Lead planning and execution of client projects to KPIs; define milestones, governance and escalation pathways.
Coordinate and lead project teams (internal colleagues and qualified external partners); allocate work based on strengths and capacity; mentor and motivate staff.
Participate in regulatory, technical and quality management processes for medical device and diagnostic clients, including IVD and in-house manufacturing contexts where applicable.
Prepare, review and compile high-quality documentation within the framework of MDS projects.
Communicate with clients and Health Authorities; support scientific advice procedures and represent clients in authority interactions.
Oversee delivery to budget and manage resolution of invoicing queries related to assigned projects.
Provide day-to-day operational support and consultancy to colleagues and clients regarding MDS Services; share MDS intelligence and best practices.
Present seminars/lectures for colleagues, clients and professional audiences; contribute to departmental expertise.
Support company strategy implementation and continuous improvement; comply with and help optimize internal processes.
Take on other reasonable tasks aligned to role and capability, as agreed with management.
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Qualifications / Skills
University degree in Science or Engineering.
Extensive experience in medical device/diagnostics regulatory and quality; strong capability to solve complex problems and operate independently.
Demonstrable leadership in mentoring/managing teams, project reengineering and change management.
Strong stakeholder management up to client department-head level; excellent written/verbal communication and presentation skills.
Business-fluent English and local language.
Deep expertise in CDx and combined studies (required).
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.
Full timeCencora 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