VP Quality, Regulatory & Clinical

Director of Quality Assurance

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

This is a Vice President, Quality, Regulatory & Clinical Affairs role in the area. This is a key executive leadership role responsible for overseeing Quality Management Systems (QMS), regulatory strategy, and clinical affairs for the Altius System. This individual will ensure compliance with FDA, EU MDR, and global regulatory requirements, lead clinical trial execution and strategy, and drive regulatory approvals, particularly PMA submissions and post-market activities. This role is critical in integrating clinical evidence generation with regulatory and quality functions to support the company's growth and commercialization objectives.

As a Director of Quality Assurance, you will:

• Serve as the Management Representative and primary FDA point of contact for regulatory activities, including audits, submissions, and compliance communications.
• Develop and implement regulatory strategies for PMA approvals, product lifecycle management, and global market entry.
• Manage regulatory submissions (IDE, PMA, supplements, post-market surveillance) and interactions with FDA and notified bodies.
• Ensure alignment of regulatory efforts with clinical strategy to support evidence-based product approvals.
• Direct and resource Quality Assurance activities, including Quality Engineering, Quality Inspection, and Product Release processes.
• Oversee the Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and global standards.
• Manage CAPA, risk management, audits, and compliance programs to maintain a culture of quality and continuous improvement.
• Ensure effective post-market surveillance processes, including complaint handling, product monitoring, and regulatory reporting.
• Develop and execute clinical trial strategies to support regulatory approvals and market adoption.
• Oversee the design, execution, and management of clinical studies (IDE trials, pivotal studies, post-market surveillance studies) ensuring adherence to Good Clinical Practice (GCP).
• Collaborate with Key Opinion Leaders (KOLs), principal investigators, and clinical sites to support clinical research initiatives.
• Ensure effective post-market clinical follow-up (PMCF) strategies for long-term product safety and efficacy monitoring.
• Align clinical strategy with regulatory and commercial objectives to generate real-world evidence (RWE) that supports market adoption.
• Partner with R&D, Medical Affairs, and Commercial teams to ensure clinical, regulatory, and quality strategies align with business goals.
• Lead and build a high-performing team across quality, regulatory, and clinical functions.
• Represent the company in external interactions with regulatory agencies, clinical investigators, and industry consortia.

What You'll Need

• 10+ years of executive leadership experience in medical device quality, regulatory, and clinical affairs, ideally in Class III (PMA) devices.
• Proven track record of PMA regulatory approvals and successful FDA interactions.
• Direct experience managing clinical trials, IDE studies, and post-market clinical surveillance.
• Strong expertise in FDA 21 CFR Part 820, ISO 13485, EU MDR, ICH GCP, and related global regulations.
• 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 Range: $205-255K Regulatory
• Bonus %: 30%

Benefits:

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