Position Title: Regulatory Affairs Specialist
Location: 2911 Dow Ave, Tustin CA 92780
- 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.
- 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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