Job Description

SUMMARY

Seeking an experienced regulatory affairs leader to guide medical device approvals, quality system compliance, and corporate regulatory programs across the U.S. and Canada. This full-time leadership opportunity involves regulatory strategy for Class II and Class III medical devices and human cell and tissue-based products, with close collaboration across quality, medical, executive, and external regulatory teams.

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.

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