Director, CMC Regulatory Affairs Medical Device and Combination Product Lead

• 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.
  

• Top of Form
• 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.
  

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

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

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