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&D

Your 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.)