Senior Project Manager
vor 2 Wochen
We are recruiting on behalf of one of our prestigious clients for a Senior Project Manager specializing in medical devices. This role is a unique opportunity to join an innovative R&D team dedicated to advancing healthcare technologies, improving patient outcomes, and shaping the future of spinal arthroplasty.
Senior Project Manager – Medical Device R&DYour main responsibilities will include:
- Leading arthroplasty product development activities
- Developing, in collaboration with the regulatory department, a strategy to access U.S. (PMA) and European markets (CE marking)
- Managing multiple projects simultaneously
- Complying with applicable regulatory requirements, including ISO 13485, 21 CFR Part 820, and MDR 2017/745 (EU)
- Collaborating with various teams within the organization (Marketing, Operations, RA/QA) at each stage of projects, from design inputs to product launch
- Participating in the design and development of new products as well as in the maintenance of existing product lines
- Defining and validating design requirements
- Ensuring prototyping and manufacturing of test devices in coordination with internal and external manufacturers
- Contributing to the design transfer of new products
- Preparing documentation, conducting risk analysis, and developing the Design Verification/Validation Master Plan, in compliance with regulatory and quality requirements
- Creating and maintaining the Design History File (DHF) related to the project
Who you are:
- Degree in mechanical engineering or equivalent, with 8 to 10 years of experience in R&D within the medical device sector
- Proven experience as an R&D Project Manager
- Experience in the medical device field for spine, orthopedics, or any related medical device industries
- Proficiency in English & French (written and spoken, with recent professional usage)
- Computer skills (Word, Excel, PowerPoint, Teams, etc.)
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