Role Description:The Director, Regulatory Affairs is responsible for leading and executing regulatory activities to support global product registrations and lifecycle compliance for the company's medical device portfolio. This role combines strategic oversight with hands-on regulatory execution, including direct authorship of complex submissions (e.g., 510(k)s), regulatory assessments, and agency interactions. This individual serves as a key regulatory lead within cross-functional teams and is accountable for ensuring that regulatory requirements are effectively translated into actionable plans and deliverables across the product lifecycle.
Key Responsibilities- 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.
Competencies- Demonstrated ability to operate at both strategic and tactical levels, with strong execution focus
- Deep technical expertise with the ability to independently author complex regulatory submissions
- Strong analytical and problem-solving skills, with the ability to navigate ambiguous regulatory pathways
- Effective communicator with the ability to influence cross-functional stakeholders and senior leadership
- High attention to detail with a consistent focus on quality and compliance
- Ability to manage multiple priorities and adapt in a fast-paced, evolving regulatory environment
- Proven leadership capability, including mentoring and guiding team members
Qualifications- 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
Work Environment:• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Travel - up to 25%??, additional may be required during execution of validation activities
