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Job

Manager of Regulatory Affairs

  • Location

    Pacific Northwest

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Avita Broukhim

  • Contact email:

    a.broukhim@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2019-09-08

  • Startdate:

    ASAP

My client is a leading IVD/Diagnostics/Medical Device company that is looking to expand the regulatory team by adding a Manager of Regulatory Affairs.


The Manager of Regulatory Affairs is responsible for acting as the representative for the regulatory team on core cross-functional aspects developing in the preparation of relevant regulatory filings to the FDA and other international registrations/submissions.

Key Responsibilities include:

  • Participating on product design teams
  • Creating, evaluating, and updating Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Reviewing labeling/promotional/advertising materials, and other documents to ensure compliance with applicable regulations
  • Maintaining current knowledge of relevant regulations, including proposed and final rules
  • Interpreting RA policies and guidance and correctly apply them as regulatory activities
  • Developing, managing, and executing regulatory plans for projects, including diagnostics, companion diagnostics, research use only, laboratory use reagents, etc.

Qualifications And 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, companion diagnostic (CDx), and life science products for translational research experience highly preferred
  • 8+ 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
  • Experience in a Molecular Biology research environment a plus
  • 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 work on product development teams
  • Intellectual curiosity and an ability to digest complex technical data desired
  • Experience on guiding cross functional teams bringing products to market from concept, development, verification & validation, clinicals, applicable submissions, clearance/approvals, marketing support for product launch is highly preferred.