Regulatory affairs specialist – fda

This is a remote-eligible position, requiring the candidate live within the U.S.

Job Purpose

The Regulatory Affairs Specialist – FDA is responsible for preparing and maintaining U.S. FDA regulatory submissions for IMMY's in vitro diagnostic products, and for securing and maintaining the clearances, registrations, listings, and licenses required to place and keep those products on the U.S. market.

Key duties and responsibilities

Bring New Products to the U.S. Market

• Determine the appropriate U.S. regulatory pathway for IMMY’s products, including classification, product code selection, and predicate identification
• Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions (as applicable), along with the technical documentation supporting each marketing authorization
• Manage Q-Submissions and other formal interactions with FDA review divisions, including tracking review timelines and responding to Agency requests
• Advise product development teams on FDA expectations for analytical and clinical performance data, including verification and validation study design

Keep Products Registered and Available

• Monitor the U.S. regulatory status of the marketed portfolio on an ongoing basis to confirm that each product remains lawfully marketable, and identify and remediate any lapse or other issues with existing registrations, listings, licenses, or authorization.
• Maintain establishment registration, device listing, UDI/GUDID data, and other institutional and/or product registrations related to U.S. market access.
• Support post-market activities for marketed products, including reportability assessments, Medical Device Reports, field actions, and reports of corrections and removals

Maintain U.S. Regulatory Compliance

• Review labeling, package inserts, instructions for use, and other materials for compliance with applicable regulations
• Verify that promotional, marketing, and sales-facing materials remain consistent with the cleared or authorized intended use
• Maintain regulatory records, submission files, FDA correspondence, and other data and files inspection-ready for audit by FDA or other regulatory authorities or authorized third parties
• Comply with, and assist IMMY in complying with, all applicable FDA medical device regulatory requirements, applicable ISO 13485 requirements, and all other applicable laws, regulations, and standards
• Monitor and assess the operational impact of regulatory changes affecting IMMY’s processes and products available in the U.S., ensuring timely planning and implementation of any changes necessary for compliance

Qualifications

Required:

• Bachelor’s degree in related discipline and 3+ years of experience guiding U.S. regulatory submissions, including having prepared and successfully submitted at least one 510(k), De Novo, or Pre Market Approval request to FDA. Title commensurate with experience; a 'Senior' designation will be considered for candidates with higher-level experience.
• Broad knowledge of U.S. FDA medical device regulations and their application to IVDs, including preSTAR/eSTAR submission format
• Broad knowledge of ISO 13485 standards requirements
• Effective technical writing and oral communication skills
• Extremely organized with high attention to detail
• Effective at multi-tasking
• Ability to work in a fast-paced, timeline-driven environment
• Ability to work independently and as part of a team
• Ability to organize information so that it is easily understood and reviewed, both internally and externally
• Ability to identify ways to improve/simplify processes

Equal Opportunity Employment:

IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy:

All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.