Emeryville Categories:
Medical Director & Regulatory Affairs Milagen
We are seeking a highly experienced candidate with an advanced medical and science degree, preferably in oncology, to lead our effort into the clinical development of the company immunodiagnostic assay pipeline, and provide strategic guidance in regulatory affairs and compliance. The successful candidate will be responsible for successfully implementing all regulatory aspects related to the development and commercialization of immunodiagnostic products.Qualifications
MPH, MD, MD/PhD with solid background in clinical research, specialty training and Board Eligibility in Medical Oncology or related field preferred
Extensive experience in pharmaceutical/diagnostic product development and related regulatory issues, and solid management experience in medical diagnostics
Thorough knowledge of all aspects of CDRH/FDA regulations regarding submission, evaluation, approval, and compliance of immunodiagnostics, including 510k, PMA, CLIA, and relevant reference laboratory accreditations
Direct liaison experience with the FDA
Very strong written, verbal, and interpersonal communication skills required, and demonstrated ability to think strategically
Excellent organizational and managerial skills
Ability to multitask and thrive in a fast-paced and challenging team environment
| Location: | 1255 Park Avenue Suite B Emeryville, CA 94608 United States |
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| Full Time |
Milagen
Investors: Auriga PartnersAll Jobs: at Milagen
| Web Site: | www.milagen.com |
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| Headquarters: | 1255 Park Avenue Suite B Emeryville, CA 94608 United States |
| Industry: | Biotechnology |
