VP Regulatory & Clinical Affairs

Vice President Regulatory & Clinical Affairs

Company: Neuros Medical

Neuros Medical is a privately held medical device company focused on improving the lives of amputees with chronic post-amputation pain. Their innovative Altius System, recently approved by the FDA, offers a non-opioid solution for managing this debilitating condition. This patient-controlled device uses electrical nerve stimulation to target and reduce pain signals, leading to significant improvements in quality of life. With a commitment to patient well-being and cutting-edge technology, Neuros Medical is dedicated to providing effective treatments for those suffering from post-amputation pain.

Why You Should Join Us

The Vice President Regulatory & Clinical Affairs is a key executive leadership role responsible for overseeing global regulatory strategy and clinical affairs for the Altius System, a Class III implantable neuromodulation device. This individual will drive regulatory approvals, lead clinical trial execution, and align clinical evidence generation with business and commercial objectives. The VP will serve as the primary regulatory authority for the company, ensuring compliance with FDA, EU MDR, and global regulatory requirements while advancing Neuros Medical's mission to bring innovative solutions to patients suffering from chronic pain.

As VP Regulatory & Clinical Affairs, you will:

Regulatory Affairs:

• Serve as the primary FDA and global regulatory contact, leading all agency interactions, audits, and regulatory submissions.
• Develop and implement global regulatory strategies to secure PMA approval, lifecycle management, and global market entry.
• Oversee and manage regulatory submissions including IDEs, PMAs, supplements, post-market surveillance, and CE Mark applications.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, IEC 60601, IEC 62304, and related global regulations.
• Align regulatory strategies with clinical objectives and commercial goals to support market adoption and reimbursement strategies.

Clinical Affairs

• Develop and execute clinical trial strategies to support regulatory approvals, reimbursement, and commercial adoption.
• Lead the design, execution, and management of IDE trials, pivotal studies, and post-market surveillance studies in compliance with Good Clinical Practice (GCP).
• Establish and maintain relationships with Key Opinion Leaders (KOLs), principal investigators, and clinical trial sites to drive study success.
• Oversee post-market clinical follow-up (PMCF) strategies for long-term product safety and efficacy monitoring.
• Generate real-world evidence (RWE) to strengthen product adoption and market positioning.

Leadership & Cross-Functional Collaboration

• Partner with R&D, Quality, and Commercial teams to align regulatory and clinical strategies with business objectives.
• Build and lead a high-performing regulatory and clinical team, fostering a culture of accountability, collaboration, and innovation.
• Represent Neuros Medical at regulatory meetings, industry consortia, and key scientific conferences.

What You'll Need

• 10+ years of leadership experience in regulatory and clinical affairs within the implantable medical device industry (AIMD experience preferred).
• Proven track record of securing PMA approvals and leading successful FDA and global regulatory interactions (AIMD experience preferred).
• Experience managing clinical trials, IDE studies, and post-market surveillance.
• Strong expertise in FDA 21 CFR Part 820, ISO 13485, EU MDR, ICH GCP, and global regulatory requirements.
• Demonstrated ability to lead cross-functional teams and drive clinical evidence generation for regulatory approvals.
• Bachelor's degree in life sciences, engineering, or related field required; advanced degree preferred.

Perks of the Job

Compensation:

• Base Salary: Market-based, DOE
• Bonus: 30%
• Equity

Benefits:

• Medical, Dental, Vision
• Basic and Supplemental Life, AD&D Insurance
• Disability
• FSA and HSA
• Various Additional and Voluntary benefits
• PTO
• Corporate Holidays