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Regulatory Affairs Specialist III/Sr. Regulatory Affairs Specialist

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


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 and EUIVDR submissions 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.

- Strong organizational skills and attention to detail required.
- Experience with Microsoft based applications and general knowledge of PC functions necessary.
- Ability to work in a fast-paced environment.
- Results and goal oriented.
- High degree of initiative with the ability to work independently with some supervision.
- Excellent oral and written communication skills.
- Ability to prepare and present information to groups.
- Ability to plan and organize work while remaining flexible.
- Excellent time management skills.
- Experience in a FDA regulated industry.
- Experience working in a cross-functional team setting is preferred.

BA degree

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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