Director, Regulatory Affairs

Overview
We are seeking a seasoned Director of Regulatory Affairs to lead global regulatory strategy, submissions, and compliance activities supporting a dynamic portfolio of medical devices. The ideal candidate brings deep expertise in U.S. FDA pathways-particularly 510(k) premarket notifications-and hands-on oversight of labeling compliance throughout the product lifecycle.

Key Responsibilities

• Develop and execute global regulatory strategies for new products, line extensions, and sustaining activities.
• Lead the preparation, submission, and maintenance of FDA 510(k) submissions, including managing internal contributors and external stakeholders.
• Oversee regulatory review and approval of product labeling, ensuring alignment with FDA, EU MDR, and other applicable global requirements.
• Serve as the primary regulatory contact for interactions with the FDA, notified bodies, and other regulatory authorities.
• Advise cross‑functional partners-including R&D, Quality, Clinical, and Operations-on regulatory requirements impacting design controls, risk management, testing strategies, and launch timelines.
• Monitor changes to global medical device regulations and translate requirements into actionable guidance for teams.
• Provide leadership, coaching, and long-term development for the regulatory affairs staff.
• Support internal and external audits, including FDA inspections and notified body conformity assessments.
• Maintain regulatory documentation, technical files, and internal procedures to ensure continuous compliance.

Qualifications

• 12+ years of regulatory affairs experience in the medical device industry.
• Proven track record of preparing and leading successful 510(k) submissions.
• Strong working knowledge of medical device labeling requirements (FDA, EU MDR, international standards).
• Solid understanding of global medical device regulatory frameworks and quality system expectations (21 CFR 820, ISO 13485, EU MDR/IVDR).
• Demonstrated ability to lead cross-functional teams and manage complex regulatory projects.
• Excellent communication, leadership, and decision-making skills.

Additional Details
This role requires a strategic mindset paired with the ability to execute detailed regulatory deliverables. Experience with both premarket submissions and postmarket compliance is strongly preferred. The ideal candidate thrives in a fast-paced, highly regulated environment and can influence at all levels of the organization.