Job ID: #6933

Regulatory Affairs Specialist

Lexington, MA
Science Science
Regulatory Affairs

 

Responsibilities of the Regulatory Affairs Specialist:

  • Maintaining regulatory data base, including establishment registration and FDA data base.
  • Maintaining international registration license data base and support international RA requests.
  • Prepare and submit 501K submissions.
  • Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products.
  • Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
  • Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.

Requirements of the Regulatory Affairs Specialist:

  • BA/BS Degree required.
  • Must have 1+ years experience with regulatory requirements for medical devices.
  • Good oral and written communications skills.
  • Working knowledge of statistics and electronic documentation and information systems.

 

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

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Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.