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Regulatory Affairs Manager

Organization
NanoString Technologies
Job Location
530 Fairview Ave N
Seattle, WA 98109
United States
Job Description

Job Summary:

The Regulatory Affairs Manager is responsible for acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to FDA and other international registrations/submissions.

Essential Functions:

  • Participate on product design teams
  • Create, evaluate, and update Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Review labeling/promotional/advertising materials, and other documents to ensure compliance with applicable regulations
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Interpret RA policies and guidance and correctly apply them as regulatory activities
  • Develop, manage, and execute regulatory plans for projects, including diagnostics, companion diagnostics, research use only, laboratory use reagents, etc.
Requirements

 Qualifications and Requirements:

  • BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus
  • Previous in vitro diagnostic (IVD) nucleic acid experience, companion diagnostic (CDx), and life science products for translational research experience highly preferred
  • 8+ years of (hands on) experience in Regulatory Affairs with FDA regulated products
  • Previous experience with 510(k), IDE, and/or PMA submissions
  • Working knowledge of FDA QSR and ISO 13485 regulations
  • Experience in a Molecular Biology research environment a plus
  • Certifications: RAC, CQA, CQM preferred
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Strong organizational skills and ability to support multiple projects
  • Proven ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals
  • Proven ability to work on product development teams
  • Intellectual curiosity and an ability to digest complex technical data desired
  • Experience on guiding cross functional teams bringing products to market from concept, development, verification & validation, clinicals, applicable submissions, clearance/approvals, marketing support for product launch is highly preferred.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.
How to Apply

Please apply to our internal website at the link provided, https://grnh.se/3b3ef7f02  

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