Regulatory Affairs Sr. Specialist or Manager

Nanostring Technologies
Job Location
Seattle, WA

401K match, ESPP, 22 Days PTO, and more

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.

•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

Relocation assistance is available for the right candidate.


Position 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
•3+ 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
•Previous in vitro diagnostic (IVD) nucleic acid experience highly preferred -or- 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
•Prove ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals
•Proven ability to work on product development teams

About Our Organization

NanoString Technologies (NASDAQ:“NSTG”) provides life science tools for translational research and molecular diagnostic products. The company's nCounter® Analysis System, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 450 peer-reviewed publications, has also now been applied to diagnostic use as the nCounter Dx Analysis System. The company's technology offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity, reproducibility and precision. The company's technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic kit to be marketed through the company's diagnostics business. Leveraging the company’s innovative platform and proven development, regulatory and commercial expertise , NanoString has established a companion diagnostics capability to enable biopharmaceuticals partners to translate biomarker discoveries into clinically-relevant diagnostics, helping to bring the right therapy to the right patient at the right time.

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