Director of Regulatory Affairs

Our client is seeking a hands-on Director of Regulatory Affairs to lead regulatory strategy and execution for new medical device product development and commercialization. This individual will play a key role in driving premarket regulatory submissions, securing product approvals, and ensuring ongoing compliance with global regulatory requirements.

The ideal candidate will bring strong technical regulatory expertise within the medical device industry, particularly with Class II and Class III devices, along with experience supporting complex product launches and the ability to provide leadership and guidance to a growing regulatory team.

Qualifications of the Director of Regulatory Affairs:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum of 5 years of regulatory affairs experience within the medical device industry.
• Demonstrated experience preparing and managing premarket regulatory submissions and obtaining product approvals.
• Strong working knowledge of FDA regulations, 21 CFR requirements, ISO standards, and international medical device regulations, including EU MDR.
• Direct experience with FDA 510(k) and PMA submissions; international regulatory submission experience preferred.
• Experience supporting Class II and/or Class III medical devices, ideally within cardiovascular or other complex device technologies.
• Ability to develop regulatory strategies while remaining actively involved in hands-on submission activities.
• Previous experience mentoring, supervising, or providing guidance to other regulatory professionals.
• Strong project management, organizational, analytical, and communication skills.

Key Responsibilities of the Director of Regulatory Affairs:

• Develop and execute regulatory strategies to support new product development, commercialization, and global market expansion.
• Lead the preparation, review, and submission of regulatory applications, including FDA 510(k), PMA, and international regulatory submissions.
• Manage regulatory approval pathways and product registrations, including U.S. and international market requirements.
• Provide regulatory guidance throughout the product development lifecycle, partnering closely with R&D, Quality, Clinical, and Commercial teams.
• Ensure products and processes comply with applicable FDA regulations, ISO standards, and international regulatory requirements, including EU MDR.
• Serve as a primary point of contact for regulatory authorities and manage responses to regulatory inquiries.
• Oversee regulatory documentation, technical files, and submission records to ensure accuracy and compliance.
• Participate in product risk management activities and provide regulatory input into design and development decisions.
• Manage regulatory project timelines, priorities, and deliverables to support successful product launches.
• Coordinate with external regulatory consultants and business partners as needed.

Occupational Code: 11-9199.01 – Regulatory Affairs Managers