Advanced Clinical

Director, CMC Regulatory Affairs Medical Device and Combination Product Lead

We are currently searching for a skilled professional to join a well-known client's team as Part Time, Remote Director, CMC Regulatory Affairs Medical Device and Combination Product Lead. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Position Summary & Responsibilities

The Director, CMC Regulatory Affairs — Medical Device and Combination Product Lead (Contractor) provides senior-level regulatory leadership and execution for U.S. and global medical device and combination product programs. This role is responsible for developing and implementing regulatory strategies, leading agency interactions, and ensuring high-quality, compliant submissions that support development, approval, and commercialization objectives. This individual serves as the primary regulatory lead for device and combination product activities, working closely with cross-functional teams and external partners to ensure regulatory requirements are fully integrated into development, manufacturing, and lifecycle plans. Key Responsibilities

• Lead the development and execution of global regulatory strategies for medical devices and combination products across development, registration, and post-approval phases.
• Plan, coordinate, and oversee preparation of regulatory submissions, including 510(k)s, CE Marking Technical Documentation, and other applicable regulatory pathways.
• Lead and manage interactions with the FDA and other global regulatory authorities, including preparation for and response to agency questions, information requests, and inspections.
• Communicate program status, milestones, risks, and challenges to senior management in a clear and timely manner.
• Ensure delivery of regulatory timelines and resolve issues or conflicts by proactively identifying and removing obstacles, including those requiring coordination with external partners.
• Provide regulatory strategy, guidance, and advice to device and combination product teams, ensuring regulatory requirements are incorporated into development and manufacturing plans.
• Independently oversee implementation of regulatory project plans for assigned products or product lines in alignment with business and commercialization strategies.
• Provide regulatory guidance throughout the product lifecycle, including design changes, human factors studies, clinical protocols, labeling, and post-market activities.
• Ensure compliance with U.S. (FDA) and international regulatory requirements for medical device and combination product registrations.
• Manage priorities and timelines across multiple submissions to ensure high-quality, on-time delivery.
• Oversee preparation of regulatory assessments related to proposed product or design changes.
• Monitor evolving global medical device and combination product regulations and assess the impact of new or changing requirements on regulatory strategies and timelines.
• Translate regulatory requirements into practical, executable work plans to support efficient development and commercialization.

Experience

• Minimum of 8 years of experience in Regulatory Affairs within a regulated industry, with significant experience in medical devices and combination products.
• Demonstrated experience leading device-related regulatory activities for combination product submissions to U.S. and international regulatory authorities, from development through approval.
• Strong working knowledge of Class II and Class III medical devices, drug-device combination products, and disposable medical devices.
• Experience providing regulatory oversight across the device development lifecycle, including design controls, risk management, human factors, and post-market activities.
• Proven ability to review and provide regulatory input on clinical and human factors documentation, labeling, and integrated regulatory summaries.
• Demonstrated ability to work effectively in a collaborative, cross-functional, and fast-paced environment focused on execution and growth.

Education

• Bachelor's degree or higher in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related scientific or technical discipline required.