Associate, Regulatory Affairs

Job Title: Associate, Regulatory Affairs

Job Description Summary: This position supports the organization and maintenance of regulatory affairs and quality system records, procedures, standards, literature, and regulatory documentation to meet company objectives.

Job Responsibilities:

• Prepare, review, and compile regulatory filings, applications, and technical documentation (such as IDE reports or supplements, Q-subs, PMA reports or supplements, product registrations, FDA small business designation request, CA manufacturing site registration or change reports)
• Monitor and research updates in local and global regulations, guidance documents, and standards
• Provide administrative support by tracking compliance spreadsheets, manage database inputs and outputs, and organize regulatory meetings or audits
• Assists in the paper and electronic (eCopy) preparation and filing of regulatory submissions.
• Coordinates international submissions, document apostille/consularization activities as needed.
• Monitors global regulations and guidance, and coordinates implementation of product and process changes for ongoing conformance.
• Handles requests for payment (including FDA User Fees), assists with expense reports, coordinates travel arrangements.
• Organization and maintenance of regulatory files, including copying, scanning, filing and other administrative activities as assigned.
• Assists with other RA and cross-functional projects and duties as assigned by manager.