SeniorRegulatoryAffairsSpecialist

## Accountabilities Support regulatory and quality activities across the product lifecycle, including design control, verification and validation, design transfer, and product modifications. Contribute to the preparation, drafting, and review of regulatory submissions for U.S. and international markets, including 510(k), Pre-IDE, EU Technical Files, and related documentation. Review and evaluate technical protocols, clinical data, and validation/verification documentation to ensure regulatory compliance. Provide regulatory input into risk management activities and lifecycle management processes in alignment with applicable standards. Support labeling and instructional material development, ensuring compliance with FDA, ISO, and international regulatory requirements. Assess regulatory impact of product design changes and change control activities, ensuring appropriate documentation and compliance actions. Support adverse event reporting, medical device reporting (MDR), and product recall or correction/removal activities. Collaborate with Sales, Marketing, and cross-functional teams to ensure promotional and technical content meets regulatory requirements. Assist in audit preparation and participate in internal and supplier quality audit activities as needed. Contribute to long-term regulatory and quality initiatives supporting organizational goals and product expansion strategies. Requirements Bachelor’s degree in Biology, Biochemistry, Microbiology, or a related scientific field. Minimum of 4 years of regulatory affairs experience in a FDA- and ISO-regulated environment. Experience preparing and supporting regulatory submissions such as 510(k), Pre-IDE, EU Technical Files, STED documentation, or equivalent. Strong knowledge of medical device regulations, including FDA 21 CFR 820, ISO 13485, ISO 14971, and related global standards. Experience in product lifecycle support, including design control, validation, and commercialization processes. Strong understanding of r