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Regulatory Specialist II
1 month ago
As a Regulatory Affairs Specialist, you are responsible for unleashing the full potential of our people and culture while simultaneously achieving timely and cost-effective manufacturing of high-quality medical devices. You are responsible for providing administrative support in ensuring compliance with all FDA and other U.S. and global regulatory requirements. This position supports internal and global customers to meet corporate submission and registration objectives for timely approval.
Position Type: Contract role for 12 mos. (through July 2025); extention possible
Essential Duties and 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.
Qualifications:
- Bachelor’s Degree (BS) or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
- 2 Years of Relevant Experience
- Strong communication skills, written and verbal