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Regulatory Affairs Specialist

1 month ago

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Our client is the worlds leading manufacturer of eye care products and medical devices They are looking for a Regulatory Affairs Specialist to join their expanding team

Location: Lake Forest, CA

Pay: $40-$45/hr

Responsibilities:

  • Work with global partners and support worldwide registrations efforts.
  • Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives.
  • Manages requests from regions and countries, provides responses and requested documentation (CFG's, FSC, certifications, Letter of Authorization, etc.) in a timely manner.
  • Prepares supporting documentation and arrange for legalizations, as required by country regulations
  • Support communications with US and international affiliates and regulatory personnel.
  • Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
  • Provides high quality regulatory support for assigned products/projects.
  • Develops documents that are clear, concise, and complete to facilitate and maintain registration renewal, tenders, and licenses.
  • Prepare, consolidate, response and follow-up on change assessments for global regulatory strategies.
  • Review and approve labeling to ensure accuracy of content.
  • Maintain a current knowledge of global medical device regulations pertaining to the distribution of products, which include facility registration and device listing.
  • Maintain documentation and a historical record for regulatory submissions.
  • Notarize regulatory registration documents as necessary. Willing to obtain notary license in California.

Qualification:

  • Bachelors Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
  • The ability to fluently read, write, understand, and communicate in English
  • 2 Years of Relevant Experience
  • Work hours: M-F 8am 5pm
  • Travel Requirements: Minimal