Head of Quality and Regulatory Consulting

Vastrax is a global full-service CRO exclusively supporting neuro innovation. From breakthrough Stroke & Aneurysm neurovascular therapies to emerging innovations in AI Imaging, Brain Computer Interface, Spine, Neuro-modulation, and Neuro-pharma, our sole focus is advancing innovation from concept to clinical success. With over 35 years of combined clinical, commercial, and regulatory expertise, Vastrax leverages its deep industry knowledge to bring cutting‑edge neurovascular products to market efficiently.

Our purpose is to help our clients solve real problems in the neuro space that affect millions of people around the globe. Our value is built every time we deliver clean data, keep a study on‑track, or help a sponsor move a therapy closer to the hands of a physician.

This is a full‑time, remote role based in Greater Boston area. The Head of Quality and Regulatory Consulting will be responsible for the company’s quality department as well as oversee the company’s strategic consulting business as it relates to regulatory programs. The individual will lead all quality efforts, overseeing quality management systems, audits, and risk assessments to ensure compliance with regulatory standards and play a key role in our consulting practice.

Responsibilities include developing and implementing quality strategies, conducting quality assurance and control processes, supporting regulatory submissions, and liaising with industry and regulatory bodies. The role requires strong leadership, collaboration with cross‑functional teams, and a commitment to upholding the highest standards of clinical research.

• Proven expertise in Quality Management, Quality Assurance, and Quality Control
• Experience with Quality Auditing and driving results through well‑structured audits
• Strong Analytical Skills to evaluate processes, identify risks, and implement improvements
• Thorough understanding of regulatory requirements in the medical device and therapeutic development industries with expertise in regulatory meetings and package development.
• Exceptional leadership and communication skills to guide cross‑functional teams and facilitate compliance processes
• Familiarity with the development of neurovascular products is advantageous
• Bachelor’s degree in a relevant field required, advanced degree preferred