Vice President of Quality Assurance / Regulatory Affairs & Compliance

VP Of Quality Assurance / Regulatory Affairs & Compliance

In April 2025, Kandu Health and Neurolutions merged to form Kandu Inc. to pioneer an integrated approach to stroke recovery, combining FDA-cleared brain-computer interface technology with personalized telehealth services. The company's IpsiHand device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function in daily home use. Combining this advanced technology with the support of expert clinicians offers a comprehensive path to recovery helping survivors improve mobility, independence, and quality of life. Kandu extends recovery beyond the hospital through principal illness navigation, providing one-on-one education, care coordination, and advocacy; grounded in clinical evidence and informed by the lived experiences of patients and their families.

The VP of Quality Assurance / Regulatory Affairs & Compliance will oversee the quality management system (QMS), ensure compliance with global medical device regulations, and provide strategic leadership to the quality and regulatory teams. This role requires a hands-on approach to quality and regulatory functions, focusing on maintaining compliance, fostering innovation, and driving operational improvements.

What You'll Do

Quality Management System (QMS)

• Maintain and improve the QMS to ensure compliance with global medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
• Ensure timely updates to policies and procedures to align with regulatory changes and industry best practices.

Regulatory Affairs

Manufacturing and Supplier Performance

Product Development and Compliance

Complaint Handling and Device Investigations

Chief Compliance Officer

What You'll Bring

What We Offer

Please note that the salary information is a general guidance only. Kandu Health, Inc. considers factors such as scope and responsibilities of the position, candidate's work experience, education / training, key skills and internal parity, as well as location, market and business considerations when extending an offer.

Kandu Health is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.