Associate, Regulatory Affairs

About the Role

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

Key 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.
• Assist in the paper and electronic (eCopy) preparation and filing of regulatory submissions.
• Coordinate international submissions, document apostille/consularization activities as needed.
• Monitor global regulations and guidance, and coordinate implementation of product and process changes for ongoing conformance.
• Handle requests for payment (including FDA User Fees), assist with expense reports, and coordinate travel arrangements.
• Organize and maintain regulatory files, including copying, scanning, filing, and other administrative activities as assigned.
• Assist with other RA and cross-functional projects and duties as assigned by manager.

Requirements & Tech Stack

• MS Office software (Word, Excel, PowerPoint)
• Copy machines, personal computers, and computer terminals.

Qualifications

• Bachelor’s degree in a technical field is required (preferably engineering or life sciences).
• No prior RA experience required.
• Strong attention to detail.
• Technical writing skills.
• Organization skills.
• Time-management skills.
• Basic project management skills.
• Basic communications skills.
• Basic interpersonal skills.
• Ability to understand scientific and health concepts.
• Typing, formatting, grammar, editing, and proof-reading skills a must.
• Ability to work in a fast-paced environment where drive is critical to success.
• Good follow-through and diligence for task completion.
• Self-motivated and self-disciplined.
• Ability to prioritize and handle multiple tasks and responsibilities.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from internal and external stakeholders.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Employee must occasionally lift and/or move up to 20 pounds.