US-CA, Director Regulatory Affairs 452431246417-MZ
|Director, Regulatory Affairs Role With International Leading Biotechnology Company|
Director Regulatory Affairs – Medical Device
-San Francisco, CA
One of the world’s largest Biotechnology Company is looking for a strategic individual to lead the Regulatory Affairs team within Class III, IVD products to PMA Stage as the Global Regulatory Director.
This company has been recently mentioned in multiple publications as having one of the leading cultural environments in the industry and they are searching for the top talent to join their ranks.
The Ideal Candidate:
- Oversee the Regulatory Affairs activities in Medical Device division
- Work as team leader to develop the global organizational regulatory strategies within Class III, IVD Products.
- Evaluate current processes & procedures in dealing with Health Authorities
- Build up of a strong organization that supports premarket, postmarket and regulatory operations including global submissions and regulatory support of clinical trials and reimbursement activities.
- Support internal and external development teams
- Serve as leader for product investigations and safety analyses on critical product issues as they occur.
- Lead strategy on global regulatory bodies and develop external global regulatory network to support activities.
- Represent company as regulatory expert externally and internally.
- Prefer minimum of 3 years of experience in IVD/medical device industry with at least 3 years of experience of in higher classification submissions, e.g. US class III PMAs- Prefer minimum of 3 years of experience working in mixed product environment: medical device, pharma, non-medical/clinical regulated
Please visit our website at www.epmscientific.com