Senior Project Manager

AXEPTA SA

1201 Genève, CH

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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.)

jid89709d5a jit1146a

Il y a 7 jours

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