Regulatory Affairs Specialist, Sr.

United States·Irvinesenior

Legal & ComplianceRegulatory Affairs Specialist

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Quick Summary

Requirements Summary

Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in the US, Canada, and the EU.

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Legal & ComplianceRegulatory Affairs Specialist

We are seeking an experienced Sr. Regulatory Affairs Specialist to support global regulatory compliance and drive high‑impact submissions. In this role, you’ll lead FDA 510(k)/PMA filings, maintain international registrations, support audits, develop SOPs, and partner closely with technical teams to ensure products meet regulatory and quality standards. If you excel at interpreting regulations, managing complex documentation, and guiding teams through compliance requirements, this is an opportunity to make a meaningful impact in a fast‑moving, innovative environment.

Essential Functions:

Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
Maintains company registrations and device listings in the US, Canada, and the EU.
Analyzes and reports department metrics.
Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
Informs coordinator of product recalls.
Performs and supports internal, external, and third-party audits.
Maintains knowledge on current regulations and guidelines.
Evaluates compliance with applicable regulations, project policies, and procedures
Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
Composes audit plans and reports.
Conducts audits and inspections of GMP and non-regulated documentation.
Tracks internal and external corrective and preventive actions.
Performs other related duties and projects as business needs require at direction of management.

Knowledge and Abilities:

Proficient knowledge of general office procedures.
Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
Proficient quantitative and analytical skills.
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.
Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
Demonstrated reliability, dependability, and flexibility in work habits.
Demonstrated attention to detail and accuracy.
Ability to analyze and collate data for presentations and reports.
Ability to prioritize and organize project tasks and goals effectively.
Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
Ability to interpret and collate data to present an accurate picture of market potential.
Ability to research new and emerging technologies and practices.
Ability to read technical diagrams, graphs, and instructions.