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Manager, Regulatory Affairs

Roche Molecular Diagnostics

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Location:
Pleasanton, CA
Posted Date:
7/29/2014
Position Type:
Full time
Job Code:
2956114057
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The selected Regulatory Affairs Manager will be expected to perform the following:
  • Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical diagnostic 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.

  • May serve as a contact with pharmaceutical partners in the codevelopment of drugs and diagnostic tests

  • 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.

  • Oversees the “agent in charge” for audits and serves as primary liaison with plant compliance officers to direct strategy and documentation requests during an audit. 
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Requirements

Education:


  • Bachelor’s degree or equivalent, required.

  • Master's degree/PhD. or equivalent, preferred.
 
Experience:
  • 8+ years regulatory affairs experience in the medical product industry, required.

  • Previous 510k or PMA experience preferred

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