Product Project Manager/R&D Project Manager
We are seeking a Product Project Manager to oversee implant and ancillary development projects, manage cross-functional teams, and ensure regulatory compliance within the medical devices industry.
Your Key Responsibilities:
* Lead medical device development projects, managing technical documentation including Design History File (DHF), Design Master Record (DMR), and Sterilization, Packaging, and Labeling (STED).
* Collaborate with R&D, Quality Assurance/Regulatory Affairs, production, and marketing teams to drive project success.
* Ensure adherence to regulatory requirements, including submission of Medical Device Regulation (MDR) and 510(k) documents.
* Promote process improvements and provide technical support across the organization.
Your Ideal Profile:
* Masters degree in medicine, biomechanics, or bioengineering.
* A minimum of five years of experience in the medical devices sector, preferably with expertise in implantable prostheses.
* Strong background in regulatory knowledge and project management skills.
* Fluency in English; proficiency in French is required, and German is an asset.