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International Regulatory Affairs Specialist

Job Summary:

Creates, evaluates, and completes International regulatory projects consistent with the company goals. Successful candidate is responsible for assembling regulatory submissions and international dossiers to non-EU territories and supporting/developing international diagnostic expansion.
 

Essential Functions:

  • Oversees select International regulatory projects consistent with the company goals. Ensures timely registration of products in compliance with applicable regulations and guidance.
  • Responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products and changes to existing products in international markets (i.e. Asia, South/Central America, Middle East, Africa and Rest of World) in partnership with other International Specialists.
  • Author and prepare documentation for International product registrations in responsible regions (i.e. Asia and South/Central America, ROW) including; annual reporting, re-licensing, and change reporting. Interact with Regulatory Affairs personnel at regulatory agencies, contract manufacturers and distributors to ensure registrations are current and compliant.
  • Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Maintains current knowledge, excellent comprehension and appropriate application of relevant regulations, including proposed and final rules.

Requirements:

  • BA/BS degree is required. Preferred education/experience areas include clinical, engineering, physical, biological, and regulatory sciences, Advanced degrees (MS, PhD., etc.) a plus
  • 3+ years of experience with international medical device regulations (IVD and/or companion diagnostic experience strongly desired) - open to more senior level candidates (4-8 years)
  • Previous experience with participating in strategic planning and regulatory filings globally (i.e. Japan, China and rest of Asia strongly preferred)
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner. Looking for a "driver".
  • Excellent organizational skills and ability to support multiple projects
  • Exemplary verbal and written skills
  • Intellectual curiosity and an ability to digest and communicate complex technical data

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*Relocation assistance is available within the US.

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