Regulatory Affairs Operations Specialist (Remote, East Coast)

*Must be located on the East Coast* *W-2 candidates only* Position Summary: The Operations Specialist, Regulatory Affairs, will support the regulatory process by managing KPIs, generating reports, and collaborating cross-functionally to ensure compliance with global regulatory requirements. This role provides process support rather than handling regulatory submissions and requires strong communication and reporting skills. Responsibilities: Collaborate with regulatory teams (US, Canada, EMEA, APAC, LatAM) and cross-functional stakeholders to implement regulatory policies, processes, and reporting tools in alignment with business goals. Support new product development, ensuring compliance with global regulatory standards. Facilitate timely review and approval of product changes (e.g., ECO/DCOs) for regulatory compliance. Keep up-to-date with global regulations and standards, providing regular updates and impact assessments. Work with Marketing, R&D, and other teams to ensure compliant product labeling and promotional materials. Maintain regulatory records and files. Perform other duties to support the regulatory function. Requirements: B.S./B.A. in Life Sciences, Engineering, or related field, or equivalent experience. 2+ years in Medical Device Regulatory Affairs. Familiarity with US FDA 21 CFR 820, EU MDR 2017/745, and IMDRF/GHTF. Proficiency in Microsoft Office, strong written and verbal communication, project management, and organizational skills.