Senior Clinical Regulatory Specialist

Responsibilities: 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.

Essential Skills: 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 supporting PMA supplements, annual reports, or other post-approval maintenance activities. Direct experience communicating with the FDA or responding to FDA questions. Strong technical writing skills with the ability to produce clear, concise, and well-structured regulatory documents. Strong document review skills with attention to detail and accuracy. Effective verbal communication skills for cross-functional collaboration and regulatory discussions. Strong project-planning and deadline-management capabilities, including managing multiple submissions and priorities. Ability to work independently while coordinating effectively with technical and business teams. Results-driven mindset with a strong sense of responsibility, urgency, and accountability. Ability to remain effective under pressure and adapt to changing priorities.

Additional Skills & Qualifications: Experience with FDA Pre-Submissions is preferred. Class II or Class III medical device experience is preferred. Orthopedic, spinal, implantable, surgical-device, or instrument-system experience is preferred but not required. Working knowledge of IDE and PMA submissions is preferred. Experience supporting IDE and PMA activities, including nonclinical, manufacturing, and clinical sections of submission packages. Experience developing or revising Regulatory Affairs SOPs is preferred. Experience training or mentoring junior Regulatory Affairs professionals is strongly valued. Experience in clinical research, clinical science, or clinical development related to medical devices is beneficial. Experience with regulatory compliance and regulatory documents across the product lifecycle is advantageous. Strong cross-functional leadership skills and the ability to coordinate activities with Product Development, Clinical Affairs, Quality, Engineering, and management. Ability to clearly explain personal role and contributions in authoring and leading regulatory submissions. Proven ability to manage multiple projects, establish priorities, and meet tight deadlines in a dynamic environment.

Work Environment: This is a full-time, on-site role based at a headquarters location in Audubon, PA, with work performed five days per week on-site. You collaborate closely with cross-functional teams including Product Development, Clinical Affairs, Quality, Engineering, and other internal partners in a professional office environment. The position offers the opportunity to work on a variety of Class II and Class III medical device submissions, gain exposure to 510(k), IDE, and PMA activities, and participate in regulatory pathway decisions, product lifecycle management, labeling reviews, and product and process change assessments. The culture emphasizes collaboration, accountability, and results, providing a setting where you can expand your submission leadership, strengthen your regulatory strategy experience, and contribute to the growth and development of the Regulatory Affairs team.

Job Type & Location: This is a Permanent position based out of Eagleville, PA.