VP Regulatory and Quality Affairs

About CAPS Medical

CAPS Medical has developed a highly selective and minimally invasive Non-thermal Atmospheric Plasma (NTAP) device designed to painlessly treat a wide range of solid tumors while preserving surrounding healthy tissue.

Joining CAPS Medical means being part of a highly skilled and motivated team, dedicated to revolutionizing cancer treatment and making a meaningful impact on patients’ lives worldwide.

Objective

We are seeking an experienced and dynamic VP of Regulatory and Quality Affairs to define, lead, and execute the company’s global regulatory and quality strategy. This is a critical leadership role responsible for securing regulatory clearances (FDA, EU, and other regions) while building and managing a robust Quality Management System (QMS).

This role requires a strategic, hands-on leader with a proven track record in the medical device startup ecosystem, capable of navigating tight timelines and delivering high-quality execution in a fast-paced, resource-constrained environment.

Key Responsibilities

Regulatory Affairs:

• Develop and execute global regulatory strategies to achieve product clearances (FDA 510(k)/PMA, CE Mark, MDR, etc.).
• Lead and manage regulatory submissions and interactions with FDA, EMA, Notified Bodies, and other regulatory agencies.
• Collaborate with cross-functional teams (R&D, Clinical, Marketing, and Commercialization) to ensure regulatory compliance throughout the product lifecycle.
• Drive risk-based decision-making to balance speed-to-market with compliance.
• Stay ahead of regulatory changes and industry trends to adapt the company’s strategy accordingly.
• Ensure compliance with ISO 13485, FDA QSR, EU MDR, and other relevant regulations.

Quality Management:

• Establish, implement, and maintain a scalable Quality Management System (QMS) suitable for a growing medical device company.
• Ensure QMS compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable global quality regulations.
• Develop and oversee internal and external audits, CAPA processes, supplier quality management, and continuous improvement initiatives.
• Define and execute quality assurance plans to support product development, validation, and commercial-scale production.
• Foster a culture of quality and compliance across all levels of the organization.

Leadership & Execution:

• Act as the primary regulatory and quality representative to senior leadership, the Board, and external stakeholders.
• Provide hands-on leadership in defining scope of work, deliverables, and execution plans.
• Operate effectively within tight schedules and resource limitations, balancing long-term strategic goals with immediate execution needs.
• Mentor and develop a high-performing regulatory and quality team as the company grows.

Requirements

Experience & Skills:

• 10+ years of experience in regulatory affairs and quality management in medical device companies (including startup experience).
• Proven track record of successfully securing FDA, CE Mark, and other international regulatory approvals.
• Deep expertise in ISO 13485, FDA QSR, MDR,  and other relevant global regulations.
• Strong experience in building and managing QMS in medical device companies.
• Hands-on experience with clinical trial planning, pre-clinical validation, and post-market surveillance.
• Demonstrated ability to operate in fast-paced, high-pressure environments with tight timelines.
• Strong leadership, communication, and cross-functional collaboration skills.

Education:

• Bachelor’s or advanced degree in Engineering, Life Sciences, MD, or a related field.

Why Join Us?

• Be a key leader in shaping the future of a cutting-edge oncology technology.
• Work closely with top-tier professionals in an innovative and mission-driven startup.
• Drive regulatory and quality success in a company poised for global expansion and commercialization.

The position is full time and on site

To apply, please submit your CV to: [email protected]