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Regulatory Affairs Specialist

2 months ago

Lake Forest, United States eTeam Full time

Regulatory Affairs Specialist II

Location: Lake Forrest, CA

Contract Duration: 12 months

Job Description:

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 (CFGs, 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.

Must haves:

• Bachelor’s 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