Sr. Regulatory Affairs Specialist

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.

Education and Experience:

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

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.