Regulatory Affairs Specialist, Sr.
About The Position
This role is responsible for preparing and submitting product registrations and submissions to regulatory bodies such as the FDA. The specialist will maintain company registrations and device listings, analyze department metrics, and support technical files and certifications for EU product registrations. Key responsibilities include managing product recalls, supporting audits, staying current with regulations, and ensuring compliance. The role also involves writing and reviewing standard operating procedures (SOPs), collaborating with technical staff, composing audit plans and reports, conducting audits, and tracking corrective actions. The position requires a strong understanding of general office procedures, MS Office Suite, and quantitative/analytical skills, along with excellent prioritization, time management, and negotiation abilities. A deep knowledge of state and federal regulations, FDA 510K, ISO 13485, and Regulatory Affairs procedures (GMP, SOP development, GMP audits) is essential. The ideal candidate will demonstrate high quality of work, reliability, attention to detail, and the ability to analyze data, manage projects, maintain confidentiality, interpret data for market potential, research new technologies, and read technical documents.
Requirements
- 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.
- Minimum five (5) years of experience in Regulatory Affairs.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
