Regulatory Specialist

Schedule: Monday–Friday, 8:00 AM–5:00 PM Industry: Medical Device Position Overview We are seeking an experienced and detail-oriented Regulatory Affairs Specialist to join our growing Quality and Regulatory Affairs team. This individual will play a key role in supporting regulatory strategies and ensuring ongoing compliance for a portfolio of medical devices across the United States, Canada, and additional international markets. The Regulatory Affairs Specialist will be responsible for supporting regulatory submissions and product registrations, maintaining regulatory documentation, reviewing labeling and promotional materials, and ensuring regulatory requirements are incorporated throughout the product lifecycle. This position will work closely with Quality, R&D, Marketing, Commercial, Operations, and external regulatory partners to support new product introductions, existing product maintenance, market expansion, and compliance activities. Key Responsibilities Regulatory Strategy & Submissions Support regulatory strategies and submissions for new and existing medical device products in the U.S., Canada, and international markets. Prepare, compile, review, and maintain regulatory submissions, product registrations, renewals, notifications, Technical Files, and other regulatory documentation. Coordinate submission activities, timelines, and cross-functional stakeholders to support timely approvals and product launches. Regulatory Compliance & Quality Systems Support compliance with FDA regulations, including 21 CFR Part 820 , ISO 13485 , MDSAP , and applicable international requirements. Monitor regulatory changes, assess their impact, and support implementation within the Quality Management System. Participate in audits, inspections, regulatory assessments, and responses to regulatory agencies and other external organizations. Labeling & Promotional Review Review product labeling, IFUs, packaging, marketing, promotional, and educational materials to ensure regulatory compliance. Partner with Marketing and Commercial teams to ensure product claims and promotional activities are accurate, supported, and aligned with approved indications. Global Regulatory & Product Lifecycle Support Support product registrations, renewals, amendments, and regulatory activities across the U.S., Canada, LATAM, Asia, and other international markets. Provide regulatory support throughout the product lifecycle, including product development, changes, deviations, CAPAs, complaints, nonconformances, and change controls. Support risk management activities in accordance with ISO 14971 and assess the regulatory impact of product, process, labeling, and documentation changes. Qualifications Bachelor's degree in Life Sciences, Regulatory Affairs, Engineering, or a related field. 5+ years of Regulatory Affairs experience within the medical device industry. Demonstrated experience supporting U.S. and Canadian regulatory submissions and registrations . Hands-on experience with regulatory submissions, including FDA 510(k) submissions and medical device technical documentation . Working knowledge of FDA medical device regulations and quality system requirements, including 21 CFR Part 820 . Strong knowledge of ISO 13485 and medical device quality and regulatory systems. Experience supporting regulatory compliance throughout the medical device product lifecycle. Familiarity with international regulatory frameworks and requirements. Ability to interpret complex regulatory requirements and apply them to business and product activities. #J-18808-Ljbffr