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Regulatory Affairs Specialist II
2 months ago
Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Lake Forest, CA.
Job Title: Regulatory Affairs Specialist II (Contract)
Pay Rate Range: $42.86/hr - $48.57/hr (W-2)
Initial Duration: 12 months with possible extension
Job Description:
• Work with global partners and support worldwide registrations efforts.
• Work in close collaboration with internal customers and support multiple projects to align on regulatory strategy to achieve business objectives.
• Manage requests from regions and countries, provides responses and requested documentation (CFG's, FSC, certifications, Letter of Authorization, etc.) in a timely manner.
• Prepare supporting documentation and arrange for legalizations, as required by country regulations.
• Support communications with US and international affiliates and regulatory personnel.
• Ensure compliance with global regulatory requirements and adherence to internal policies and processes.
• Provide high quality regulatory support for assigned products/projects.
• Develop documents that are clear, concise, and complete to facilitate and maintain registration renewal, tenders, and licenses.
• Prepare, consolidate, respond 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 a notary license in California.
Required:
• Bachelor’s Degree or Equivalent years of directly related experience
• Two years of experience
