Fractional VP of Clinical, Regulatory, and Quality

Theta Neurotech is developing a wearable EEG patch designed to predict epileptic seizures ahead of onset, targeting people living with drug-resistant epilepsy. The Fractional VP of Clinical, Regulatory, and Quality will own the clinical development pathway, regulatory submissions to FDA and international agencies, and quality management systems aligned to ISO 13485 and 21 CFR Part 820.

The role involves close collaboration with cross-functional teams across R&D, product, and operations. Responsibilities span clinical study design and execution, audit readiness, risk management frameworks, documentation standards, and mentoring team members. The position also contributes to the long-term commercialisation strategy for the device.

• Lead clinical study design, execution, and post-market surveillance for the wearable EEG device.
• Oversee regulatory submissions and manage interactions with FDA and relevant international agencies.
• Develop, implement, and continuously improve quality management systems in line with ISO 13485 and 21 CFR Part 820.
• Establish risk management processes and maintain documentation and audit readiness.
• Collaborate with R&D, product, and operations teams to align clinical and regulatory strategy with commercialisation goals.
• Mentor team members in quality and regulatory best practices.

• Demonstrated expertise in quality control and quality assurance for medical devices or related healthcare technologies.
• Proven track record in regulatory affairs, including FDA submissions and international compliance.
• Advanced understanding of clinical trial design, development, and post-market surveillance, preferably in neurology or adjacent areas.
• Familiarity with applicable standards including ISO 13485, 21 CFR Part 820, and relevant IEC standards for neurotech or wearables.
• Experience leading cross-functional teams and influencing strategy at an executive level.
• Graduate degree in Medicine, Biomedical Engineering, Regulatory Science, or a related field, or equivalent professional experience.

Theta Neurotech is a healthtech startup building a wearable EEG patch aimed at predicting epileptic seizures to improve patient safety and daily independence. The company is focused on developing innovative medical device solutions for individuals living with drug-resistant epilepsy.