Regulatory Affairs Specialist

Regulatory Affairs Specialist – International

REMOTE

Reports to:

Manager, Regulatory Affairs

The Regulatory Affairs Specialist, International plays a key role in supporting our client’s global regulatory strategy by helping prepare and maintain submissions, registrations, and compliance documentation across U.S. and international markets. This position works collaboratively with cross-functional teams including R&D, Quality, and Marketing to ensure products meet applicable regulatory requirements throughout their lifecycle.

• Prepare and submit regulatory filings for U.S. and international markets, including 510(k) s, STED files, Design Dossiers, and Rest-of-World documentation, under the guidance of senior RA staff.
• Develop, organize, and maintain product Summary Technical Documentation (STED) to support global registration activities.
• Coordinate international registration activities on behalf of customers and global distribution partners.
• Review quality records, preclinical data, and clinical materials to verify completeness and accuracy in support of regulatory submissions.
• Manage routine annual regulatory requirements, including FDA establishment registration updates, Canadian device license renewals, FURLS listings, and state license maintenance.
• Support Notified Body audit preparation by compiling documents, organizing files, and tracking follow-up actions to closure.
• Maintain ISO and CE certification documentation to ensure all internationally marketed devices are accurately represented.
• Review labeling, IFUs, promotional materials, and marketing content for regulatory compliance and escalte identified issues to senior team members.
• Contribute to New Product Development by researching product classifications and compiling documentation to support applicable regulatory pathways.
• Collaborate with R&D and sustaining engineering teams to review protocols and technical reports, and help identify regulatory documentation needs.
• Identify potential regulatory concerns and communicate them to senior RA staff for guidance and resolution.
• Participate in risk management and post-market surveillance activities, including data collection, documentation, and regulatory reporting.
• Gather information and assist in the preparation of adverse event and vigilance reports in accordance with applicable requirements and timelines.
• Monitor global regulatory updates and standards changes, and help maintain current internal regulatory libraries and tracking tools.
• Maintain documentation for Authorized Representatives and In-Country Caretakers across international markets.
• Review QA/RA-related customer and distributor contract sections for regulatory accuracy and coordinate with senior RA staff for final approval.
• Support regulatory activities associated with product notifications, advisory notices, and recall management.
• Gather data and assist in evaluating the regulatory impact of proposed preclinical, clinical, and manufacturing changes.
• Contribute to change control processes by collecting, organizing, and maintaining required regulatory documentation throughout the product lifecycle.

• Bachelor’s degree in a scientific, technical, or related field required; M.S. or M.B.A. is a plus
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a plus
• 2–5 years of experience in a regulated industry, preferably medical devices or combination products
• Advanced degree may be considered in lieu of years of experience
• Understanding of ethical standards governing the regulatory profession, clinical research, and the regulatory submission process
• Familiarity with regulatory history, guidelines, policies,…