They key responsibilities of the Senior Regulatory Affairs Specialist are:Develop and execute regulatory strategies to support product development, submissions, and post-approval activities. Prepare, review, and submit regulatory filings, including but not limited to IN - Ds, ND - As, BL - As, 510(k)s, ID - Es, supplements, amendments, and annual reports, as applicable. Serve as a primary regulatory contact for internal stakeholders, providing clear guidance on regulatory requirements, risks, and timelines. Interface with regulatory authorities (e.g., FDA) to manage inquiries, meeting requests, and formal correspondence. Ensure compliance with applicable U.S. and international regulations, guidance documents, and standards. Support labeling development and review to ensure regulatory compliance and alignment with approved claims. Contribute to regulatory impact assessments related to product changes, manufacturing updates, quality events, and lifecycle management activities. Partner cross-functionally with Quality, Clinical, R&D, Manufacturing, and Commercial teams to support regulatory objectives. Monitor regulatory intelligence and assess potential impacts of changing regulations on existing and future products. Assist in the development, maintenance, and improvement of regulatory processes, procedures, and documentation. Support inspections, audits, and regulatory commitments, as needed. Mentor junior regulatory team members and provide subject-matter guidance when appropriate. . The Successful Applicant. A successful Senior Regulatory Affairs Specialist will have:Bachelor's degree in a scientific, engineering, or healthcare-related discipline (required); advanced degree preferred . years of progressive experience in Regulatory Affairs within a regulated healthcare environment (pharmaceutical, medical device, biologics, or combination products). Demonstrated experience preparing and managing regulatory submissions to the FDA and/or international regulatory bodies. Strong working knowledge of applicable FDA regulations (e.g., 21 CFR) and relevant international standards. Excellent written and verbal communication skills, with the ability to clearly convey regulatory concepts to diverse audiences. Proven ability to manage multiple priorities, meet deadlines, and work effectively in a fast-paced environment. High attention to detail, strong organizational skills, and sound problem-solving abilities. Ability to work independently while collaborating effectively within cross-functional teams.