Regulatory Affairs Specialist III

Regulatory Affairs Specialist This position is responsible for ensuring that pre-market and/or post-market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross-functional software development meetings; prepare software-specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements. Key accountabilities include advising and directing teams on regulatory requirements related to new product development or significant changes, ensuring test protocols and reports for new products or significant product changes meet regulatory requirements for intended market(s), authoring regulatory plans as regulatory lead for new products or significant product changes, acting as lead on regulatory filings for market clearance, licensing, registration, and legalization, both domestic and international, reviewing and approving labeling and marketing materials associated to regulatory filings, advising and directing teams on regulatory requirements for on-market product changes, authoring regulatory determinations as regulatory lead for on-market product changes, ensuring company site and device registrations are compliant with applicable domestic and international regulations, reviewing and approving changes orders for product labeling changes, regulatory procedure changes and marketing communications as required, increasing working knowledge of regulations, standards, company SOPs and tools, assisting in interactions regarding regulatory affairs with all functional areas of the company as required including senior management, assisting in tracking standards, regulations and all applicable requirements, and other duties as assigned. Secondary functions include assessing regulatory gaps and taking the appropriate corrective actions, as needed, supporting internal and external audit as required, participating in regulatory improvement projects as required, and budget management (if applicable). Internal networking/key relationships include working closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirements, ability to negotiate and influence others in establishing direction toward improved regulatory and enhanced compliance, ability to effectively communicate regulatory requirements to a broad population of constituents. Skills and capabilities include ability to read and interpret domestic and international regulatory/quality standards related to our products, working knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirements, demonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectives, recognition of when to escalate issues to management or consult with more senior staff members. Competencies include attention to detail, accuracy, performance standards, communication, discretion, multi-tasking, collaboration, independence, professionalism, takes initiative, problem solving, and decision making. Minimum knowledge and experience required for the position include a bachelor's degree or higher, preferably in science and/or regulatory, minimum of 5-years' experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years' experience with an advanced degree, duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulations, understanding of the application of regulatory principles in the areas of pre-market or post-market compliance, knowledge of FDA, ISO, MDSAP and international country regulations, knowledge of design control requirements and understanding of GMP, and language: English. International mobility is not required, and travel requirements are less than 10% of time. The annual base salary range for this role is currently $105K to $130K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Created: 2026-03-06