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Regulatory Affairs Specialist III

Pleasanton, CA
Position Role/Tile: Regulatory Affairs Specialist III
Location:  Pleasanton, CA.                                                                                                                                        

Duties Plans own work assignments; may plan and/or delegate work to others.
Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.
Compiles materials required in submissions, license renewals and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical and development protocols.
Determines data requirements and risks for earliest possible approvals of regulatory applications.
Oversees the collection of documents, records, reports and data from Development, Clinical Affairs, Quality and Operations Departments for inclusion in regulatory documents.
Manages submissions for FDA product approval including 510(k)s, PMAs, INDs, BLAs as assigned.
Reviews product labeling/advertising to ensure compliance with federal regulations.
Prepares international registration dossiers for use in international registration by Client Diagnostic Affiliates.
Works on diverse problems requiring significant analysis and evaluation of intangible variables; may refer to established precedents and policies.
May represent Regulatory Affairs on project teams and is responsible for monitoring the activities associated with the project plan.
Representative on Corporate Export Control Board and responsible for designated export activities including export license applications.
Skills Ideally 5 years of related Regulatory Affairs experience or more. Needs to be a quick learner and team player
Keywords Education Bachelor's Degree in scientific discipline or equivalent combination of education and work experience.

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677

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