Senior Project Manager, Medical Devices

Overview Geistlich is seeking a Senior Project Manager to lead complex medical device development programs in regenerative medicine, guiding projects from concept through design transfer to market readiness. You will collaborate with R&D, Process Development, Quality, Regulatory, Operations, Medical Affairs, and Marketing to translate innovative ideas into successful products in a highly regulated environment.

Responsibilities - Lead cross-functional medical device development programs from concept to market readiness. - Own timelines, budgets, resources, risks, deliverables, and stakeholder alignment. - Drive decisions and governance across project teams. - Ensure compliance with Design Controls and applicable quality and regulatory requirements (ISO 13485, ISO 14971, FDA/EU MDR). - Coordinate design planning, design reviews, verification and validation, risk management, and design transfer. - Proactively manage risks, dependencies, and critical issues. - Report project status and recommendations to senior management.

Qualifications - Degree in Engineering, Biomedical Engineering, Life Sciences, Natural Sciences, Pharmacy, or related field. - 8+ years leading multidisciplinary teams; 5+ years in Medical Devices or tightly regulated industries. - Proven experience leading cross-functional product development projects. - Hands-on experience with Design Controls from user needs through design transfer. - Strong knowledge of ISO 13485, ISO 14971, and FDA and/or EU MDR requirements. -

Senior Project Manager, Medical Devices

Overview Geistlich is seeking a Senior Project Manager to lead complex medical device development programs in regenerative medicine, guiding projects from concept through design transfer to market readiness. You will collaborate with R&D, Process Development, Quality, Regulatory, Operations, Medical Affairs, and Marketing to translate innovative ideas into successful products in a highly regulated environment.

Responsibilities - Lead cross-functional medical device development programs from concept to market readiness. - Own timelines, budgets, resources, risks, deliverables, and stakeholder alignment. - Drive decisions and governance across project teams. - Ensure compliance with Design Controls and applicable quality and regulatory requirements (ISO 13485, ISO 14971, FDA/EU MDR). - Coordinate design planning, design reviews, verification and validation, risk management, and design transfer. - Proactively manage risks, dependencies, and critical issues. - Report project status and recommendations to senior management.

Qualifications - Degree in Engineering, Biomedical Engineering, Life Sciences, Natural Sciences, Pharmacy, or related field. - 8+ years leading multidisciplinary teams; 5+ years in Medical Devices or tightly regulated industries. - Proven experience leading cross-functional product development projects. - Hands-on experience with Design Controls from user needs through design transfer. - Strong knowledge of ISO 13485, ISO 14971, and FDA and/or EU MDR requirements. -