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- 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.