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Director, Regulatory Affairs

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

Job Summary:

Regulatory affairs leadership position within NanoString Technologies. The Director, Regulatory Affairs responsible for guiding regulatory affairs department daily activities culminating in the preparation of relevant regulatory filings to FDA and global regulatory authorities, with a focus on companion diagnostics. Responsibilities include life-cycle management of 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.

The Regulatory Director has company-wide influence, responsibility and functions as an internal expert resource. The individual will be actively called upon to provide regulatory guidance to business unit leadership and project teams.

Requirements

Essential Functions:

  • Develop and implement regulatory strategies to achieve global regulatory approval timelines for new products and feature enhancements
  • Guide regulatory affairs staff to successfully participate in product design teams
  • Create, evaluate, and update Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced, and guides staff in these activities
  • Review labeling/promotional/advertising materials, and other documents to ensure compliance, and guides staff in these activities
  • Maintain current knowledge of relevant regulations, including proposed and final rules. Interpret RA policies and guidance and correctly apply them as regulatory processes, and guide staff in these activities
  • Represent regulatory affairs as part of cross functional teams resolving on market product issues including complaints, CAPA, MDRs and field actions. Provide regulatory input during audits and in adverse event reporting
  • Coach, develop and motivate the team to build a sustainable pipeline of leaders for the organization. Act as a model leader in the organization

Qualifications and Requirements (Education, Experience, Specific Skills):

  • 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
  • 10+ years of (hands on) experience in Regulatory Affairs with FDA regulated products
  • Minimum 3 years direct people management experience
  •  Previous experience with 510(k), IDE, and/or PMA submissions
  • Strong knowledge of FDA QSR and ISO 13485 regulations
  • Experience directly working with the FDA to through the submission process and to resolve on market issues
  • Experience in a Molecular Biology research environment
  • 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 motivate and develop junior staff

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/1382fb3a2  

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