Director of Regulatory Affairs

RESPONSIBILITIES: Lead regulatory planning and submission activities for new and existing products, including PMAs, supplements, 510(k)s, 513(g) requests, pre-submissions, annual reports, and supporting documentation. Maintain U.S. and Canadian device registrations and listings, coordinate required renewals, and support state licensing, permits, and compliance reporting. Direct quality system oversight in alignment with 21 CFR Part 820 and ISO 13485, including management reviews, internal procedures, and quality agreements with vendors. Oversee complaint handling, adverse event and medical inquiry processes, and applicable medical device reporting and recall requirements under 21 CFR Parts 803 and 806.Partner with medical and quality colleagues on audits, investigations, root cause assessments, and corrective and preventive actions. Serve as a primary regulatory contact for leadership, consultants, regulatory authorities, and international partners. Oversee corporate compliance practices consistent with applicable U.S. fraud and abuse requirements and recognized industry standards. Assess product labeling, promotional materials, and training resources for regulatory accuracy and compliance. Develop and update policies, procedures, work instructions, and technical records; support inspections and internal or external audits. Provide guidance and training to employees and supervise assigned regulatory and quality personnel.

QUALIFICATIONS: Bachelor’s degree in a science, healthcare, or closely related discipline. At least 10 years of relevant experience spanning regulatory affairs, compliance, and quality systems. Regulatory Affairs Certification required. Working knowledge of FDA requirements for Class II and Class III medical devices, human cell and tissue-based products, and Canadian medical device regulations. Experience with medical device submissions, quality management systems, and applicable FDA reporting obligations. Strong technical writing skills, including preparation of regulatory reports, procedures, policies, and supporting documentation. Ability to manage multiple priorities independently, communicate across functions, and travel when needed.

BENEFITS: Lead high-impact regulatory initiatives that support product development and market access. Work directly with senior leadership and collaborate with multidisciplinary and international teams. Expand expertise across U.S. and Canadian regulatory pathways, quality systems, and corporate compliance. Opportunity to shape regulatory strategy, mentor colleagues, and strengthen quality practices across the organization.