Senior Regulatory Affairs Specialist / Regulatory Affairs Manager

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

Benefits include but are not limited to: Medical, Dental, Vision, Stock Options, ESPP, Matching 401K, transportation assistance, wellness reimbursement, PTO, and more...

Job Description

Job Description:

The successful candidate is responsible for acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to FDA, with a particular focus on companion diagnostics.

Essential Duties:

  • Participation on product design teams
  • Creates evaluates and updates Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Reviews labeling/promotional/advertising materials, and other documents to ensure compliance
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Interprets RA policies and guidance and correctly apply them as regulatory activities
  • Development, management and execution of regulatory plans for large-scale projects, including companion diagnostics
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
  • 4+ 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
  • Strong intellectual capacity and curiosity desired
  • 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
About Our Organization

NanoString Technologies (NASDAQ: NSTG) 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.

Organizations performing cancer research, biomarker validation and screening, and next-generation sequencing validation are rapidly adopting the nCounter® Analysis System. By providing simple, multiplexed digital profiling of single molecules, the NanoString platform represents a natural, digital downstream companion to next-generation sequencing and enables researchers to embark on studies that were previously inconceivable.

Leading researchers and institutions are finding that NanoString's nCounter system provides the ideal platform on which to validate their discoveries and translate them into clinically useful diagnostic assays. The nCounter system is uniquely positioned to support translational research because it provides more reproducible results than methods requiring amplification, and generates high-quality data from the difficult sample types common in clinical research, including Formalin-Fixed Paraffin-Embedded (FFPE) tissues.

In addition to continuing to extend the applications for the nCounter system in the discovery, target validation and routine testing segments of the genomics research market, the company's goal is to become the platform of choice for diagnostic testing based on multiplexed gene signatures that can be offered in hospitals and pathology laboratories worldwide, following appropriate regulatory approvals. These two synergistic areas of business focus provide researchers with a seamless transition from discovery to diagnostics.

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