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Regulatory Affairs Specialist IV/Regulatory Affairs Manager

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


Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products (including compliance).  
Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings.
Monitors and assesses Regulatory developments (e.g. Federal Register publication/notices, FDA guidelines) related to the Company's products.
Reviews product labeling to ensure conformance with Regulatory requirements and/or approved product claims.
May serve as a contact with affiliates to achieve international registration of devices.
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.

- 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/entrepreneurial team 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.
- 2 years experience in a FDA regulated industry, or equivalent is preferred.
- Experience working in a cross-functional team setting is preferred.

- B.S./B.A. in a science, engineering, or related technical field.

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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