Regulatory Affairs Specialist

Description

Essential Functions:

• Prepares and submits product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
• Maintains company registrations and device listings in the US, Canada, EU, and other countries.
• 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 policies as necessary.
• Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
• Coordinates with international regulatory team members regarding product change and regulatory notification and/or approval requirements.
• Serves as subject matter expert for Regulatory Affairs.
• Provides management with ideas for developing and implementing strategies and processes.
• Analyzes advertisements, labels, and public communication documents for regulatory compliance.
• Reports significant regulatory issues related to a product's release to appropriate parties.
• Evaluates product compliance to applicable regulations and project requirements.
• Participates and assists with FDA facility inspection, notified body audits, and other government inspections as needed.
• 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 1 year of experience in Regulatory Affairs.
• Previous SaMD (software as a medical device) experience required.

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.