Senior Regulatory Affairs Specialist

San Francisco  ‐ Onsite
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Keywords

Description

A global medical device company is seeking a Senior Specialist for their growing product lifecycle group. The Senior Regulatory Affairs Specialist provides and often leads regulatory support for new and existing class II and III medical device products.
  • Prepares timely amendments, supplements, annual reports and other regulatory documents for review and approval by Manager.
  • Interfaces with other departments to provide Regulatory advice and obtain the necessary documents and draft reports and narrative components in accordance with regulatory agencies' guidelines.
  • Prepare and submit PMA or 510(k)s (FDA) and/or International submissions experience to obtain regulatory clearances for new products and product changes in a timely manner.
  • Prepare "Memo to File" reports to support internal filings for product development projects and product changes.


Requirements/Qualifications
  • 4+ Years Regulatory Affairs Experience
  • BA/BS Degree (Engineering or Scientific Field a plus)
  • Expertise in Pre-Market notification 510(k) guidelines and/or International Regulatory Affairs
  • RAPs (preferred)


To find out more about Real please visit www.realstaffing.com
Start date
04/2013
From
Real Staffing
Published at
17.04.2013
Project ID:
522426
Contract type
Permanent
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