About Us:

VideaHealth is a cutting-edge AI-powered solution for dentistry, developed by a team of seasoned leaders, engineers, AI scientists, and clinicians spun out of MIT. Our vision is to be the first company to diagnose a billion people globally. Our product is already used by thousands of dental clinicians to improve the quality of care through faster diagnoses, increase operating efficiencies, and improved patient understanding.

About the Role:

We are looking for a Director of Quality & Regulatory Affairs to join a talented and rapidly growing team. This individual will lead the company’s quality management effort and work closely with our leadership, regulatory consultants, and delivery teams delivering value to customers.This position is empowered to create change within the organization and for our customers daily, we're excited to work with you on revolutionizing dental care!

Your key responsibilities include:

• Anticipate the needs of the company, grow and lead the the quality organization

• Responsible for maintaining and improving the Quality Management System to meet the business needs of the company and regulatory requirements of the US FDA and any other state or international requirements, as applicable.

• Responsible for reporting on the performance of the quality system to Management with Executive Responsibility

• Ensure the Quality Management System functions are performed, including: Document control, design control, risk management, cybersecurity controls, complaint handling, internal/external audits, CAPA system, training system, and supplier quality among others.

• Act as the focal point for interaction with US FDA, State, Notified Body, and other regulatory agencies, as appropriate.

• Provide quality leadership for product development teams delivering next generation products to the market

• Lead premarket submissions such as FDA 510(K) submissions including the clinical testing alongside the Clinical Department

• Guide, coach, recruit, and develop organizational talent

• Monitor and ensure compliance with company and applicable policies and procedures through the implementation of a robust quality system and communication/reporting to regulatory authorities

• Develop and execute organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills

• Work in partnership with Engineering to support design enhancements for existing products

• Monitor post market performance of commercialized products and make recommendations to improve patient and customer outcomes

• Investigate and optimize complaint process to reduce complaints

• Ensure product safety, reliability, and quality through the effective use of planning, risk assessment, statistical methods, and process control during the design and development stages of the product life cycle

• Ensure continuous improvement in product performance by incorporating learnings into new product development

• Acts as Management Representative for FDA and ISO 13485

• Acts as Person Responsible for Regulatory Compliance (PRRC) for EU MDR

• Acts as Information Security Officer & Privacy Officer for HIPAA and similar health information management regulations

• Leads cybersecurity external audits such as SOC2

• Communicate with clients around VideaHealth’s quality and compliance processes and performance metrics

• Collecting regulatory requirements and regulatory monitoring of applicable future regulations, standards and guidance documents

• Working knowledge of ISO 14971

Required Experience and Qualifications

• Bachelor degree, technical discipline preferred, such as engineering, biology, chemistry, or computer science.

• Minimum of 10+ years of relevant experience in medical device or regulated industry (RA, QA, clinical, security)

• Experience working with software development teams

• Experience with regulatory submissions for SaMD, AI/ML, or digital health such as FDA 510(K)s

• Excellent verbal and written communication skills. Proficient English, both written and oral, is crucial.

• Outstanding interpersonal and communication skills for bridging technical and business participants, for negotiating timelines and for effective collaboration

• Strong working knowledge of US and international medical device regulations, including 21 CFR 820, EU MDR, ISO 13485, and Health Canada requirements.

• Hands-on experience establishing and maintaining medical device quality management systems.

• Demonstrated success in presentation of Quality Management System to auditors, including audit mitigation.

• Strong problem-solving skills and the ability to make timely, risk-based decisions.

Preferred Qualifications

• Masters degree in relevant discipline

• Technical background (e.g. formal education in Engineering, Science related field)

• Experience with software development and/or software testing such as IEC 62304

• Experience interacting with and presenting to clinicians and customers

• Experience designing clinical studies and IRB processes

• Experience with medical imaging systems and handling data in the form of medical images or patient reports

• Familiarity with statistical concepts to inform the design of clinical studies (e.g. study endpoints) or performing statistical analyses

• Ability to consolidate and analyze diverse data sources

• Track record of scientific writing, e.g. published scientific articles or white papers