RA Specialist

Location: San Diego, California, United States
Salary: competitive
Job Type: Contract
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A Regulatory Affairs Consultant position is available at an exciting Class I & II Medical Device company located in San Diego, CA (via Real Staffing). This is a long-term contract position that requires a commitment of 40hrs/week on-site in San Diego.

Responsibilities

  • Assist in the development of global and domestic regulatory strategies
  • Assist with 510(k) submissions and ensure compliance with FDA and FTC
  • Assist with EU MDR projects
  • Maintain US Registrations and device listings
  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance
  • Collaborate with other departments - Quality, Operations, Product Development to ensure timeliness of regulatory submissions
  • Develop, execute, and analyze regulatory data and for management review
  • Identify potential regulatory approval risks based on changes in regulations, standards, county-specific issues, or other unique characteristics of the project

Overall, this is a wonderful opportunity to join a growing organization during an exciting time. This skilled individual will join a fun team, contributing to the development of a cutting-edge medical device. If you are interested in learning more about this opportunity, apply to this advert!

Sthree US is acting as an Employment Business in relation to this vacancy.

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