Senior Manager, Regulatory Affairs

Organization
NanoString Technologies
Job Location
530 Fairview Ave N
Seattle, WA 98109
Salary
Competitive
Benefits

Comprehensive

Job Description

Job Description:

The successful candidate is responsible for assisting in guiding regulatory affairs activities for the regulatory affairs department culminating in the preparation of relevant regulatory filings to FDA and global regulatory authorities, with a particular focus on companion diagnostics.  Responsibilities will include life-cycle management of select pipeline products that are both marketed and in development, maintenance of needed registrations and certifications, and alignment of regulatory strategy with corporate strategy in conjunction with senior management.

 

Requirements

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 and/or companion diagnostic (CDx) experience highly preferred
  • 6+ years of experience in Regulatory Affairs with FDA regulated products, minimum of 2 years of successful management experience
  • Previous experience with 510(k), IDE, and/or PMA submissions
  • Good knowledge of FDA QSR and ISO 13485 regulations
  • Experience in a Molecular Biology research environment
  • Strong intellectual capacity and curiosity, and ability to digest complex technical data
  • 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, and equivalent in international markets
  • Proven ability to motivate and develop junior staff
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.