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Regulatory Affairs Specialist

Job Summary:

The Regulatory Affairs Specialist evaluates and completes US, Canada, and EU regulatory projects consistent with the company goals. This individual is responsible for preparing regulatory submissions for the US FDA, Health Canada and the EU.   Responsibilities include acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to the FDA or other government agencies.

Essential Duties:

  • Oversee/support regulatory projects consistent with the company goals
  • Leadership and/or assistance in creating timely regulatory document packages for submissions and registrations of new and mature products
  • Manage and maintain regulatory files based on regulatory and post-market requirements
  • Compile, coordinate, and format all materials required in submissions, license applications/amendments, technical file documentation and annual reporting
  • May have direct interaction with regulatory agencies on defined matters.
  • Contribute to the creation and execution of regulatory strategies for clinical trial applications
  • Recommend changes for labeling/promotional/advertising materials, manufacturing, marketing and clinical protocol for regulatory compliance to the appropriate regulations, as needed
  • Assist in the creation, evaluation, implementation and update of internal regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Maintain awareness, excellent comprehension and appropriate application of relevant regulations including proposed and final rules.
  • Requires some supervision with latitude for independent judgment

Requirements:

  • BA/BS degree is required, preferred education/experience areas include bioengineering, physical, biological, and regulatory sciences, Advanced degrees (MS, PhD., etc.) a plus
  • Direct experience interacting/interfacing with Regulatory Agencies (e.g. FDA, Notified Bodies, and/or Health Canada, etc.)
  • 2-4 years of experience with US FDA, Health Canada and/or EU regulations at a diagnostic or a medical device company (experience may be combined with pertinent education)
  • Knowledge of US FDA, Health Canada and/or EU laws, regulations, standards and guidances that affect diagnostic products
  • Working knowledge of FDA Quality System Regulations and ISO 13485
  • Previous experience with preparing and submitting 510(k), IDE, and/or PMA, MDLA, Design Dossiers, Technical Files or other regulatory submissions and some interaction with regulatory authorities for registrations
  • Previous in vitro diagnostic (IVD) experience highly preferred -or- experience in a Molecular Biology research environment
  • Excellent communication skills; both oral and written
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Strong intellectual capacity and curiosity desired
  • Strong organizational skills and ability to support dynamic programs
  • Proven ability to work on product development teams
  • Certifications: RAC, preferred

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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