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Senior Regulatory Affairs Specialist

1 month ago

Santa Clarita, United States BioTalent Full time

*Hybrid on-site role in Valencia, CA - at least 1 day per week


The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally.


Duties and Responsibilities

  • Perform gap analyses between new/revised regulations and standards and the Quality Management System (QMS).
  • Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance.
  • Compile Clinical Evaluation Plans and Reports.
  • Assess reportability of changes to: labeling, design, materials, manufacturing process, sterilization or packaging.
  • Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc.
  • Compile needed post-market reports.
  • Facilitate the completion of actions identified as a result of post-market reports.
  • Compile necessary documentation for the creation of technical files. Maintain technical files.
  • Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies.
  • Develop responses to questions or deficiency letters from regulatory agencies and notified bodies.
  • Use technical/clinical writing skills to clearly describe technical information for third party reviewers.
  • Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.).
  • Maintain registrations, certifications, and/or licenses, as applicable.
  • Assist new product development teams to provide regulatory support to the project
  • Develop positive working relationships with other departments.
  • Actively participate in third party audits of.


Qualifications

  • Medical Device experience (doesn’t need to be ortho, but have taken a device from feasibility thru market and post-market,) design control for at least 1 product line, US/EU MDR, International is a nice to have
  • EU Experience: drafting technical files, corresponding with notified bodies, answering Q&A
  • US Experience: 510ks, LTFs, interacting with FDA, resolving additional questions
  • Hands-on contribution to authorship of 510(k) submissions