International Regulatory Affairs Sr. Specialist or Manager | GenomeWeb

International Regulatory Affairs Sr. Specialist or Manager

Organization
Nanostring Technologies
Job Location
Seattle, WA
Salary
DOE
Benefits

Relocation assistance w/in US/CAN, 401K match, ESPP, PTO, Wellness Reimbursement and more

Job Description

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.

Responsibilities:
•Oversees International regulatory projects consistent with the company goals. Ensure timely registration of products in compliance with applicable regulations and guidance’s.
•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. EU, Asia, South/Central America).
•Author and prepare documentation for International product registrations in responsible regions (i.e. EU, Asia and South/Central America) 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 of relevant regulations, including proposed and final rules.
•Interprets RA policies and guidance and correctly apply them as regulatory activities

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
•Previous experience with global regulatory filings (i.e. EU, Asia and South/Central America)
•Strong interpersonal skills with the ability to influence others in a positive and effective manner
•Excellent organizational skills and ability to support multiple projects
•Excellent verbal and written skills

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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