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Director, Regulatory Affairs

Expired Job

Nanostring Technologies, Inc. Seattle , WA 98113

Posted 4 months ago

Country: United States

Type: Full Time

Experience: Experienced

Job Summary:

The Director of Regulatory Affairs, reporting to the Vice President of Regulatory Affairs and Quality Assurance, is responsible for guiding regulatory affairs activities for the regulatory affairs department culminating in the preparation of all regulatory filings to FDA (510(k), IDE, and/or PMA) and global regulatory authorities, with emphasis in IVDD, medical device, and companion diagnostics (CDx). This role requires regulatory experience in multiple phases of medical device IVD and partnered pharmaceutical development across various disease areas. This individual will closely interact with multiple intra-departmental, inter-departmental, and corporate partner functions to ensure high quality and timely regulatory submissions that support NanoString's product development strategies. Demonstrated leadership ability in mentoring, building successful goal-oriented teams and supervising staff to support products spanning Life Sciences, RUO, and Molecular Diagnostics.

Essential Duties:

  • Provides leadership and mentorship on projects including regulatory strategies, requirements for clinical studies, strategic development plans, risk assessments, and critical issue management.

  • Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions supporting IVDD, medical device, and CDx.

  • Provides regulatory strategic input to stakeholders and supports projects, including but not limited to regulatory requirements for clinical studies, general GMP/CMC regulatory strategies and marketing approval in domestic and international markets, regulatory development plans, risk assessments and critical issue management.

  • 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.

  • Supports Management Review reporting function.

  • Assists in RA department planning and budget forecasting.

  • Interpret RA policies and guidance and correctly apply them as regulatory activities, and guide staff in these activities

  • Develop, manage, and execute regulatory plans for assigned projects, including companion diagnostics, and guide senior staff in these activities

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 relevant experience in Regulatory Affairs with FDA regulated products.

  • Previous experience with 510(k), IDE, and/or PMA submissions.

  • Strong knowledge of FDA QSR and ISO 13485:2016 MDSAP 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.

  • Demonstrated ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals.

  • Proven ability to motivate and develop junior and senior staff.

  • Strong organizational skills and ability to support multiple projects.

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.

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Director, Regulatory Affairs

Expired Job

Nanostring Technologies, Inc.