Medical Device Project Manager (commercial) at RDI Technology Partners in Gibbstown, New Jersey

Posted in Other about 15 hours ago.

Type: full-time





Job Description:

RDI Technology Partners is an established professional search firm. We are working on an EXTREMELY high-priority search for a Medical Device Project Manager with at least 3 years (more is better) of paid experience, along with commercial product ISO and FDA experience.

Our client is a life-changing bioscience/medical device start-up funded by a successful, publicly traded biotech company. They are significantly impacting the injury/surgical healing process and human health. This is a permanent HYBRID (mainly remote) W2 employee position. When onsite, this position will be working near Gibbstown, NJ, halfway between Philadelphia and Wilmington. There will be some travel to the Raleigh/Durham, NC area as well.

Experience with the following is important:

Understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements
  • Monitoring the design and development process, ensuring adherence to specifications, and addressing technical challenges
  • Overseeing the design transfer, V&V and production phases of the medical device, including clinical trials, to verify safety and efficacy
  • Stage gate design control experience in highly regulated development and manufacturing environments

Our client offers a competitive and comprehensive compensation/employee benefits package including medical, dental, and vision and PTO. Only U.S. persons (no visa holders) can be considered.

Our client is already making a HUGE difference in human health and healing. Don't miss this ground floor opportunity!

Please let us know immediately if you are interested in learning more. We can schedule a short fact-finding Zoom call to provide you with significantly more detail and review your relevant experience.
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