Lead Regulatory Compliance Specialist

2 weeks ago

Santa Clarita, California, United States BioTalent Full time

*Hybrid on-site role - at least 1 day per week

The Lead Regulatory Compliance Specialist plays a crucial role in facilitating regulatory processes that ensure compliance and approval for products on a global scale.

Key Responsibilities

  • Conduct comprehensive gap analyses between newly established or revised regulations and the Quality Management System (QMS).
  • Evaluate published literature, preclinical findings, clinical investigation outcomes, field performance data, and other pertinent post-market surveillance information to assess device safety and efficacy.
  • Prepare Clinical Evaluation Plans and Reports.
  • Determine the reportability of modifications related to: labeling, design, materials, manufacturing processes, sterilization, or packaging.
  • Collaborate with various departments to collect data necessary for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, and more.
  • Compile essential post-market documentation.
  • Facilitate the execution of actions identified through post-market reports.
  • Assemble required documentation for the development and maintenance of technical files.
  • Assist in drafting submission documents for regulatory authorities (e.g., FDA, Health Canada) and Notified Bodies.
  • Formulate responses to inquiries or deficiency letters from regulatory agencies and notified bodies.
  • Utilize technical and clinical writing skills to effectively communicate technical information for third-party reviewers.
  • Execute submissions through the regulatory agency's electronic submission systems, as applicable.
  • Maintain necessary registrations, certifications, and licenses.
  • Support new product development teams by providing regulatory guidance throughout the project lifecycle.
  • Foster positive working relationships across departments.
  • Actively engage in third-party audits.

Qualifications

  • Experience in the medical device sector, with a proven track record of guiding a device from feasibility through market launch and post-market phases, including design control for at least one product line; familiarity with US/EU MDR is advantageous.
  • Experience in the EU: drafting technical files, liaising with notified bodies, and addressing inquiries.
  • Experience in the US: handling 510(k) submissions, LTFs, interacting with the FDA, and resolving additional queries.
  • Hands-on experience in the authorship of 510(k) submissions.

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