Lead Regulatory & Clinical Affairs for a first-of-its-kind Neuromodulation Device

Our client, a high-growth, privately held medical device company, is advancing pain management for amputees suffering from chronic post-amputation pain. Their FDA-approved, non-opioid neuromodulation device delivers targeted electrical nerve stimulation to provide patient-controlled pain relief. As they scale for commercialization, they seek an experienced executive to lead global regulatory strategy and clinical affairs.

Key Responsibilities Include:

• Serve as the primary regulatory authority, leading FDA and global regulatory interactions, audits, and submissions.
• Develop and execute regulatory strategies to drive PMA approval, lifecycle management, and market expansion.
• Oversee clinical trial execution, including IDE, pivotal, and post-market surveillance studies.
• Align regulatory and clinical strategies with commercial objectives to support market adoption and reimbursement.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory standards.
• Build and lead high-performing teams, fostering collaboration and innovation across regulatory and clinical functions.

What You’ll Need:

• 10+ years of leadership in regulatory and clinical affairs within implantable medical devices; AIMD experience preferred.
• Proven success securing PMA approvals and managing FDA and global regulatory processes for implantable medical devices; AIMD experience preferred.
• Expertise in clinical trial strategy, IDE studies, and post-market surveillance.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and ICH GCP requirements.
• Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred.
• Ability to drive clinical evidence generation and regulatory approvals in a fast-paced, growth-focused environment.

About Floodgate Medical

Talent Acquisition Solutions for the MedTech Industry | Improving Lives by Uniting Great People with Great Companies At FloodGate Medical, we put people first. Headquartered in Tampa, FL with a broad national presence, our team engages in high-powered talent acquisition and candidate representation by partnering with the top medtech companies. With over 20 years in the medical device and biotech recruiting space, our principals have completely reinvented the recruitment process through constant evolution, innovation and customized solutions. Candidates and companies alike rely on us to find that perfect match. Our goal is to dazzle from start to finish while improving lives by uniting great people with great companies.

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