Director, Regulatory Affairs - CA


Company Profile:  A manufacturer of rapid point-of-care diagnostic test devices, this company utilizes a biotechnology approach (to identify novel proteins or combinations of proteins that function as disease biomarkers) to create a portfolio of diagnostic tests for cardiovascular diseases and drug overdose.

 
Responsibilities:
Director Regulatory Affairs is responsible for leading the day-to-day activities of Regulatory Affairs with specific emphasis on the preparation, review and evaluations of documents for FDA submission. Also responsible for assuring that all regulatory requirements/commitments are met with respect to the development and approval of new medical devices; providing regulatory advice to other functional areas with regards to the regulatory aspects of medical device development; interacting directly with FDA personnel via written correspondences, teleconferences and meetings; and, working in cooperation with R&D, Marketing and Medical Affairs, to identify, investigate, evaluate and shape strategy for all new products and technology opportunities.
 
Specific Responsibilities:

Requirements:
 
Compensation & Relocation:

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