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Regulatory Affairs Manager

  • Location

    Seattle, United States

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    $130,000 - $150,000

  • Contact:

    Callum Sparkes

  • Contact email:

    callum.sparkes@catalystcareers.com

  • Job ref:

    60660

  • Published:

    about 1 month ago

  • Expiry date:

    2021-09-22

  • Consultant:

    Callum Sparkes

An opportunity to join an innovative Seattle-based biotech who are at the forefront of cutting-edge technology in the booming diagnostics space. Working closely with some of the most respected regulatory professionals in the exciting genomic-aided diagnostics field, you'll be able to build and develop existing skills while simultaneously being a part of commercializing ground-breaking, life saving tech. 

Core responsibilities

  • Writing, reviewing, and submitting 510(k)s for IVD products used for cancer diagnosis.
  • Cross functional projects, working closely with R&D, operations, and quality in order to achieve company and regulatory goals.
  • Creating, evaluating, and updating Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained, or enhanced to streamline the process.
  • Providing insightful, and informed decisions on the most likely successful route to gain regulatory clearance.
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Interpret RA policies and guidance and correctly apply them as regulatory activities
  • Develop, manage, and execute regulatory plans for projects, including diagnostics, companion diagnostics, research use only, laboratory use reagents, etc.

Experience Required to be Considered

  • 5+ years experience in Medical Devices Regulatory Affairs with FDA regulated products, with prior exposure working with diagnostics (IVD, CDx) an advantage in all applications
  • BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences.
  • Working knowledge of FDA QSR and ISO 13485 regulations, and 510(k), IDE, and/or PMA submissions experience
  • 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 desired.