Job Title: Sr. Director/VP, Quality and Regulatory Affairs

Reports to: EVP of Product Engineering

Job Location: Santa Clara (Onsite)

We are taking medical imaging where you never thought it could go - everywhere. We're aiming to build a future healthcare system that's unconstrained by the four walls of a hospital and engineered for a world where providers can see into every patient immediately. We are building an affordable handheld ultrasound device and workflow platform for a new era of medical care.

Job Summary:

The Senior Director/VP of Quality and Regulatory Affairs is a critical member of the leadership team, responsible for establishing and leading the company’s quality and regulatory function, as well as the champion for Exo’s total quality management system.

This leader oversees all aspects of quality assurance, quality control, regulatory affairs, R&D quality, compliance, production/supplier quality and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations.

The Senior Director/VP will work closely with Engineering, Operations, Sales, Marketing and Clinical Affairs.

Job Responsibilities (but not limited to):

• Authorized to act as the Regulatory Affairs representative to external regulatory agencies (ex. FDA, Notified Bodies, Competent Authorities etc) and industry groups.
• Management Representative for the Quality System.
• Drive and cultivate a culture of quality throughout the company to help ensure compliance
• with all applicable regulations, guidelines, and corporate standards, policies, and procedures.
• Develop, implement and maintain a Quality System in compliance with all applicable
• regulations (FDA, ISO 13485, CMDR, etc).
• Establishes domestic and international regulatory strategy for Exo’s products. Educates the
• organization on deliverables to achieve the regulatory goals.
• Prepare and / or oversee FDA and International submissions which could include 510k, De
• Novo, International Technical Documentation (MDR), Design Dossier, product registrations,
• MDRs, Vigilance Reporting requirements and follow-up reports.
• Establish strategic goals for Quality and Regulatory Affairs.
• Ensure that the company, its contractors and vendors are prepared for FDA and Notified
• Body inspections.
• Oversee Quality in production, to ensure Exo’s product meet set specifications.

• Develop departmental budget and product cost structure and identify cost improvement opportunities. Have full budget responsibility and accountability. Review and approve departmental expense and capital budget. Lead and develop a team of regulatory and quality staff based in the U.S. and overseas

Requirements:

• Bachelor’s degree or Master’s degree in a scientific discipline with at least 15 years of work experience in medical device Quality and / or Regulatory Affairs, preferably to have had some focus in the SaMD and AI application of a medical device.
• Expert knowledge of FDA Regulations, ISO13485, European MDR, CMDR and other countries medical device regulations
• Experience shepherding the Quality organization’s contributions to successful commercialization of a product.
• Demonstrated experience defining the quality and regulatory strategy for the company for hardware and software. Experience working with an AI-based product preferred.
• Support GDPR and ISO activities as needed. Must be a safety and compliance role model
• Experience leading high performing RAQA teams with strong people leader skills and the ability to mentor and develop a team
• Experience hosting FDA and Notified Body Audits
• Track record of strong personal performance combined with demonstrated ability to
• build and lead high performing teams in a fast growth environment
• Demonstrated problem-solving and critical thinking skills
• Travel may be required up to 10% of the time.

Salary: $200,000K - $280,000K