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About our client
Our client is a premier molecular diagnostics business that uses proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers. The company develops diagnostic products based on these as well as other known markers.
Position	Location
Regulatory Affairs Manager	California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Recommend regulatory strategies for the earliest possible product registrations and approvals, both domestically and internationally 2) Participate in project teams as a core team member 3) Generate document packages for regulatory submissions, license renewals, and annual registrations 4) Review and recommend changes for labeling, marketing literature, and clinical protocols for regulatory compliance with standards, regulations, and procedures 5) Evaluate the impact of changes to or generation of internal documents and policies 6) Keep abreast of all regulatory registration regulations, approval processes, current industry practices, standards, and changes 7) Facilitate interactions and negotiations with the FDA, authorized representatives, notified bodies, and other regulatory agencies to achieve approval to sell products
Requirements
1) Successful completion of BS or MS degree in a scientific discipline or equivalent 2) Minimum 6-7 years' experience 3) Minimum of 5 years' regulatory experience in the diagnostics or medical device industry inclusive of four or more years' regulatory submissions experience in 510(k)s and international registrations 4) Strong experience in GMP/QSR 5) Knowledge of diagnostic medical devices