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Regulatory Affairs Manager

Company: Apple & Associates

Location: Syracuse, NY

Contact Information


Name: Joan Harris
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Job Description

Our client is a growing Medical Device Manufacturer, with multiple locations and excellent career opportunities.
The Regulatory Affairs Manager will be responsible for maintaining the FDA and international regulatory files and prepare submissions of product registrations, including 510k's and technical product registrations. This position works with the product development teams and project teams to identify regulatory requirements and assures that labeling is in compliance.


Job Requirements

Qualified candidates will have:
 

  •  Minimum three to five years of Regulatory Affairs experience in the Medical Device industry
  • Experience with submissions, domestic and international
  • Demonstrated managerial/leadership skills.


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