Regulatory Affairs Specialist, Sr.
$84,716–$120,000 year
On-siteIrvine, California, United States
Irvine, California, United StatesOn-siteFull Time$84,716–$120,000 yearSenior LevelLarge
Full TimeSenior LevelLarge
Job Summary
Lead FDA 510(k)/PMA filings, maintain international registrations across the US, Canada, and EU, and support audits while developing SOPs. Prepare and submit product registrations to regulatory bodies, analyze department metrics, and inform coordinators of product recalls. Conduct GMP and non-regulated documentation audits, track corrective and preventive actions, and collaborate with technical staff to ensure compliance with current regulations and quality standards. Review and write policies as business needs require.
Required Qualifications
- Minimum five (5) years of experience in Regulatory Affairs
- Demonstrated knowledge and understanding of related State and Federal regulations and procedures
- 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 high standard of quality of work
- 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
- 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
Desired Qualifications
- Bachelor's degree in related field preferred
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