Senior Clinical Regulatory Specialist

Senior Clinical Regulatory Specialist

The Senior Clinical Regulatory Specialist supports the preparation, review, and submission of U.S. regulatory filings for Class II and Class III medical devices. In this role, you collaborate closely with Product Development, Clinical Affairs, Quality, Engineering, and other internal teams to lead 510(k) submissions, coordinate supporting documentation, obtain required approvals, and respond to FDA questions. You also assist with IDE and PMA submissions, contribute to nonclinical, manufacturing, and clinical sections of PMA packages, review clinical study data for regulatory reporting, and support PMA supplements and annual reports.

This position is ideal for an experienced Regulatory Affairs professional who wants to take meaningful ownership of premarket submission activities, influence regulatory strategy, and mentor less-experienced team members.

• Prepare, author, review, and submit U.S. premarket regulatory documentation for Class II and Class III medical devices, with a primary focus on 510(k) submissions.
• Coordinate internal review and approval of regulatory documents and ensure submission packages are complete, accurate, and compliant with FDA requirements.
• Respond to FDA questions and information requests by gathering data from cross-functional teams and drafting clear, well-supported responses.
• Support IDE and PMA submissions by contributing to nonclinical, manufacturing, and clinical sections of submission packages.
• Assist with PMA supplements, annual reports, and other post-approval maintenance activities to ensure ongoing regulatory compliance.
• Evaluate the regulatory impact of new products and changes to existing products, processes, manufacturing activities, drawings, and labeling.
• Determine appropriate regulatory pathways for new or modified products and document decisions using Regulatory Pathway Forms and Note-to-File documentation.
• Review Regulatory Pathway Forms, Document Change Orders, and related documentation to assess whether product changes require additional submissions or supporting evidence.
• Review clinical, manufacturing, and nonclinical information for inclusion in regulatory submissions and ensure data are presented accurately and clearly.
• Review product labeling and supporting documentation to confirm alignment with regulatory requirements and approved indications.
• Develop, revise, and implement Regulatory Affairs standard operating procedures (SOPs) to improve submission quality and consistency.
• Train and mentor junior Regulatory Affairs professionals on regulatory processes, documentation standards, and submission best practices.
• Lead and coordinate submission activities across Product Development, Clinical Affairs, Quality, Engineering, and other internal stakeholders.
• Manage multiple regulatory projects simultaneously, establish priorities, and meet cross-functional deadlines in a fast-paced environment.
• Communicate regulatory requirements, timelines, and risks clearly to technical and business teams and help guide decision-making throughout the product lifecycle.
• Exercise sound regulatory judgment and analytical skills when assessing product changes, labeling updates, and lifecycle management decisions.
• Maintain a results-driven approach, taking ownership of submission execution and ensuring high-quality, timely regulatory deliverables.
• Operate effectively under pressure, adjust to changing priorities, and maintain accountability for regulatory outcomes.

• Bachelors degree is required.
• Minimum of five years of related medical device Regulatory Affairs experience.
• Strong experience preparing, authoring, reviewing, and leading U.S. medical device premarket submissions, particularly 510(k) s.
• Strong understanding of U.S. medical device regulatory requirements throughout the product lifecycle.
• Demonstrated experience coordinating and supporting 510(k) submissions, including documentation preparation, internal approvals, and FDA interactions.
• Experience reviewing clinical, manufacturing, and nonclinical information for inclusion in regulatory submissions.
• Experience assessing product, process, manufacturing, drawing, and labeling changes for regulatory impact.
• Experience determining regulatory pathways for new or modified medical device products.
• Familiarity with Regulatory Pathway Forms, Document Change Orders, and Note-to-File documentation.
• Experience reviewing product labeling and supporting documentation for regulatory compliance.
• Experience…