Senior International Regulatory Affairs Specialist

Organization
NanoString Technologies
Job Location
530 Fairview Ave N
Seattle, WA 98019
Salary
Competitive
Benefits

Comprehensive

Job Description

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

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
  • 4+ years of experience with international medical device regulations (IVD and/or companion diagnostic experience strongly preferred)
  • Previous experience with global regulatory filings (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
  • 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
About Our Organization

NanoString Technologies is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications.

NanoString's products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under direction of Dr. Leroy Hood. The company was founded in 2003 with an exclusive license to develop and market the technology. In 2008, NanoString launched its first commercial instrument system and began international sales operations with its first multiplexed assays for gene expression analysis. In 2010, the company launched new applications for the system to support microRNA analysis and copy number variation detection, and in 2013 launched Prosigna®, its first in vitro diagnostic product for prognosis of early stage breast cancer.

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