Vice President 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
- Direct the company’s regulatory strategy including guiding IFU expansion, reviewing design changes for regulatory impact, and driving compliance with regulatory reporting requirements
- Create regulatory submissions and interface with regulatory authorities
Manufacturing and Supplier Performance
- Partner with the manufacturing team to drive improvements in supplier performance and manufacturing efficiency.
- Enhance inspection and test methods throughout the production process in collaboration with manufacturing and engineering teams.
- Ensure that product development activities incorporate quality requirements, including user need validations, regulatory compliance, and design change approvals.
- Analyze design and engineering changes to develop regulatory strategies and ensure compliance throughout the product lifecycle.
Complaint Handling and Device Investigations
- Manage the complaint handling and material review board processes to ensure thorough investigations and timely closure of issues.
- Provide technical leadership for hands-on device failure investigations, identifying root causes and implementing corrective actions.
Chief Compliance Officer
- Ensure the company remains compliant with all applicable regulations including QMSR, HIPAA, CCPA, etc
- Create and manage audits, remediation plans, and company training to compliance requirements
What You’ll Bring
- Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.
- Minimum of 10-15 years of experience in quality and regulatory roles within the medical device industry, with hands-on experience in electromechanical devices.
- Proven success in healthcare compliance environment
- Experience managing QMS compliance, regulatory submissions, and product lifecycle management.
- Excellent problem-solving, analytical, and communication skills.
- Proficiency in leading cross-functional teams and driving organizational improvements.
- Certification in quality or regulatory fields (e.g., CQE, CQA, RAC) is a plus.
What We Offer
- Competitive Compensation ($220,000 - $250,000 p/year)
- Insurance (Medical/Dental/Vision)
- 401(k) with company
- Unlimited PTO & Holidays
- Life Insurance, LTD and STD
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.