Regulatory Affairs Specialist, Sr.

Prismatik • Irvine, CA

79d • $83,898 - $120,000

About The Position

The position involves preparing and submitting product registrations and submissions (510(k), PMA) to the FDA and other regulatory bodies. The candidate will maintain company registrations and device listings in the US, Canada, and the EU, analyze and report department metrics, and support and maintain technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark. The role also includes informing the coordinator of product recalls, performing and supporting internal, external, and third-party audits, and maintaining knowledge on current regulations and guidelines. The candidate will evaluate compliance with applicable regulations, project policies, and procedures, review and write standard operating procedures (SOPs) and other RA/QA policies as necessary, and collaborate with technical staff to foster understanding of SOPs and guidance documentation. Additionally, the candidate will compose audit plans and reports, conduct audits and inspections of GMP and non-regulated documentation, track internal and external corrective and preventive actions, and perform other related duties and projects as business needs require at the direction of management.

Requirements

• Bachelor’s degree in related field preferred.
• Minimum five (5) years of experience in Regulatory Affairs.
• 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.

Responsibilities

• Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
• Maintain company registrations and device listings in the US, Canada, and the EU.
• Analyze and report department metrics.
• Support and maintain technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
• Inform coordinator of product recalls.
• Perform and support internal, external, and third-party audits.
• Maintain knowledge on current regulations and guidelines.
• Evaluate compliance with applicable regulations, project policies, and procedures.
• Review and write standard operating procedures (SOPs) and other RA/QA policies as necessary.
• Collaborate with technical staff to foster understanding of SOPs and guidance documentation.
• Compose audit plans and reports.
• Conduct audits and inspections of GMP and non-regulated documentation.
• Track internal and external corrective and preventive actions.
• Perform other related duties and projects as business needs require at direction of management.

What This Job Offers

• Education Level: Bachelor's degree