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.