Position Title: Regulatory Affairs Specialist

Location: 2911 Dow Ave, Tustin CA 92780

Essential Functions:
  • Maintains company registrations and device listings in the US and EU.
  • Supports and maintains technical files, IVD certifications, and declarations of conformity in support of EU product registrations/CE mark.
  • Maintains knowledge on current regulations and guidelines.
  • Prepare and submit product registrations and submissions (510(k)) to FDA and other regulatory bodies.
  • Evaluates compliance with applicable regulations, project policies, and procedures.
  • Reviews and writes standard operating procedures and other RA/QA policies as necessary.
  • Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
  • Coordinates with international regulatory team members regarding product change and regulatory notification and/or approval requirements.
  • Serves as subject matter expert for Regulatory Affairs.
  • Provides management with ideas for developing and implementing strategies and processes.
  • Ensure the QA programs and policies are maintained and modified regularly.
  • Analyzes marketing ads, labels, and public communication documents for regulatory compliance.
  • Reports significant regulatory issues related to a product’s release to appropriate parties.
  • Evaluates product compliance to applicable regulations and project requirements.
  • Participates and assists with FDA facility inspection, notified body audits, and other government inspections as needed.
  • Performs other related duties and projects as business needs require at the direction of management.
Education and Experience:
  • Bachelor’s degree in related field preferred.
  • Minimum two (2) years of experience in Regulatory Affairs.
  • Bachelor's Degree required in the life sciences or engineering with a minimum of 2 years direct experience in Regulatory Affairs within an IVD Industry.
  • International experience preferred.
Special Requirements/Certification:
  • Certification in regulatory affairs desired (i.e., RAC)
Knowledge and Abilities:
  • Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
  • Proficient quantitative and analytical skills.
  • Extensive experience reviewing technical documentation.
  • Demonstrated prioritization and time management skills.
  • Demonstrated negotiation abilities.
  • Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
  • Demonstrated high standard of quality of work.
  • Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
  • Experience with CAPA
  • Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
  • Demonstrated attention to detail and accuracy.
  • Ability to analyze and collate data for presentations and reports.
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