Associate, Regulatory Affairs
About The Position
This position supports the organization and maintenance of regulatory affairs and quality system records, procedures, standards, literature, and regulatory documentation to meet company objectives. The role prepares, reviews, and compiles regulatory filings and technical documentation; monitors local and global regulations and guidance; and provides administrative support for compliance tracking, regulatory submissions, meetings, audits, expenses, and travel. It also coordinates international submissions and related apostille or consularization activities, and helps implement product and process changes to maintain ongoing conformance. The position requires a technical bachelor's degree, preferably in engineering or life sciences, but no prior regulatory affairs experience. The successful candidate will demonstrate strong attention to detail, technical writing, organization, time management, communication, and basic project-management skills. The role involves handling confidential product information and working with internal and external stakeholders in a fast-paced environment.
Requirements
- Bachelor's degree in a technical field; engineering or life sciences is preferred.
- No prior regulatory affairs experience is required.
- Strong attention to detail, technical writing, organization, and time-management skills.
- Proficiency in Microsoft Office software, including Word, Excel, and PowerPoint.
- Basic project-management, communication, and interpersonal skills, and ability to understand scientific and health concepts.
- Typing, formatting, grammar, editing, and proofreading skills.
- Ability to work in a fast-paced environment where drive is critical to success.
- Good follow-through and diligence in completing tasks.
- Self-motivated and self-disciplined, with the 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, and effectively present information and respond to stakeholder questions.
- Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to solve practical problems, analyze information systematically, develop alternative solutions, interpret varied instructions, and act decisively.
- Employee must occasionally lift and/or move up to 20 pounds.
Nice To Haves
- Engineering or life sciences degree.
Responsibilities
- Prepare, review, and compile regulatory filings, applications, and technical documentation, including IDE reports or supplements, Q-subs, PMA reports or supplements, product registrations, FDA small business designation requests, and California manufacturing site registration or change reports.
- Monitor and research updates in local and global regulations, guidance documents, and standards.
- Track compliance spreadsheets, manage database inputs and outputs, and organize regulatory meetings or audits.
- Assist with paper and electronic (eCopy) preparation and filing of regulatory submissions.
- Coordinate international submissions and document apostille or consularization activities as needed.
- 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.
- Assist with other regulatory affairs and cross-functional projects and duties as assigned by the manager.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
