Director, Regulatory Affairs

Role Overview

• Serve as the regulatory lead for product development and lifecycle management, providing both strategic direction and hands-on execution of regulatory deliverables.
• Author, review, and finalize regulatory submissions (e.g., 510(k), PMA, international dossiers), ensuring high-quality, technically sound, and compliant submissions.
• Lead preparation and management of U.S. FDA and global regulatory submissions, including direct interaction with regulatory authorities and notified bodies.
• Drive regulatory strategy development for new products, product changes, and global market expansion, while ensuring alignment with business objectives.
• Act as the primary regulatory representative on cross-functional teams, influencing decisions related to product design, claims, testing, and labeling.
• Evaluate and interpret regulatory requirements, guidance documents, and regulatory intelligence, translating them into actionable plans.
• Provide expert regulatory input into design control, risk management (ISO 14971), clinical, and preclinical activities to support submissions and compliance.
• Assess the regulatory impact of product and process changes, and define appropriate submission strategies or justification for non-submission.
• Lead and support regulatory agency interactions, including pre-submissions, deficiency responses, and meeting preparation.
• Ensure timely responses to regulatory inquiries and manage commitments to regulatory bodies.
• Oversee and contribute to labeling and promotional material review to ensure compliance with applicable regulations and approved claims.
• Provide regulatory leadership in quality system activities, including CAPAs, nonconformances, field actions, and change control.
• Support and participate in audits and inspections (FDA, Notified Bodies), including preparation and response activities.
• Mentor and provide guidance to junior regulatory staff, while remaining actively engaged in execution.
• Contribute to the development and continuous improvement of regulatory processes, SOPs, and internal best practices.

Requirements

• Bachelor’s degree (B.S. or B.A.) in Engineering, Life Sciences, or related field required
• 8–10+ years of regulatory affairs experience in an FDA-regulated industry (medical device preferred)
• Demonstrated hands-on experience authoring and leading 510(k) submissions
• Strong knowledge of FDA regulations, global regulatory frameworks, and medical device requirements
• Experience interacting directly with FDA and Notified Bodies
• Solid understanding of design controls, product development, and lifecycle management
• Advanced degree preferred

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development