Senior Quality & Regulatory Specialist

Job Description

About Us:
VideaHealth is a cutting-edge AI-powered solution for dentistry, developed by a team of business operators, 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, lower operating costs, and improved patient understanding.

About this Position:
As the Senior QA/RA Specialist you will help shape the future of oral care by combining your own excellence in quality and regulatory processes with close collaboration with the technical Machine Learning (ML) and Operations teams. As a key member of the Quality & Regulatory Department, your expertise will aid the growth of the software as a medical device (SaMD) Quality Management System (QMS). You will develop a roadmap and lead the implementation of QA/RA and security software modules. You will drive cybersecurity management alongside the Information Security Officer and may be the deputy to the Management Representative and/or Information Security Officer.

You will lead premarket regulatory submissions for United States FDA clearances, European Union CE Mark, etc. and live out the Quality Management System (QMS) to deliver AI models with real world impact. Your regulatory knowledge may lead institutional review board (IRB) activities and clinical investigation study oversight.

We are looking for an individual with a strong QA/RA background who is not shy to take proactive responsibilities in pursuit of operational excellence across the organization. This is an impactful role that will grow your technical and leadership skills and ultimately improve the quality of dental care millions of people receive. Your contributions will play a key role in building a great company from an early stage and we are excited to work with you to revolutionize dentistry!

This is a hybrid position in our Boston HQ.

Requirements:

• Bachelor’s Degree in a relevant discipline. Master’s Degree preferred.

• 8+ years of experience in a quality & regulatory role

• Experience, certification(s) or credential(s) for quality auditing, regulatory affairs, software quality assurance, or cybersecurity.

• Strong communication and collaboration mindset with external and internal stakeholders.

• Build strong relationships by being a collaborative and dependable teammate across the software and machine learning teams as well as other key organizational stakeholders.

• Strong technical or medical regulatory writing ability.

• Experience with developing, implementing, and monitoring QMS processes such as document control, CAPA, complaint handling, and training.

• Experience with internal and/or external QMS audits. Lead internal auditor experience and/or experience in the front room as auditee is required.

• Experience with cybersecurity and electronic protected health information (ePHI) processes. This includes working knowledge of HITRUST, SOC2, HIPAA, and/or GDPR.

• Experience with medical device premarket clearance submissions (USA FDA 510(K), EU MDR, others internationally) is required.

• Experience managing or implementing internal business systems (eQMS, cybersecurity framework management software, etc.).

Bonus Points For:

• Experience with SaMD testing processes is a plus.

• Knowledge of or experience with statistical techniques.

• RAPS certification

You’ll thrive here if you have:

• A strong sense of initiative alongside the ability to follow up and get things done.

• Ownership and vision for QMS and regulatory processes to ensure they are value added.

• Adaptable and creative approach to problem solving.

• A sense of curiosity and interest in the Machine Learning and Dental industries.

What We Offer:

• Fast paced and collaborative work culture in which you can gain experience, grow your technical skills and work on a wide variety of challenges over your time with us.

• Competitive pay, equity and benefits.

• Technical challenges on the leading edge of innovation where software, machine learning, and compliance meet.

• Mentorship opportunities with the department lead; who has over 15 years of experience.

Don’t meet all the listed requirements? We still encourage you to apply! We are looking for the right teammate who is excited to contribute to our mission and are flexible on level of experience.

VideaHealth is committed to cultivating an equitable, inclusive, and supportive environment for all employees. We believe this environment creates a safe space for employees to share their experiences, brainstorm ideas, and grow their careers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

VideaHealth is supported by some of the best investors in the world, having raised over $67M in Venture Capital from Tier 1 investors such as Threshold ventures, Spark Capital (Twitter, SnapChat, SmileDirectClub), Zetta Venture (Kaggle), and Pillar VC (PillPack), as well as angel investors such as Frederic Kerrest (Co-founder of Okta). Our work has been featured in TechCrunch, Wall Street Journal, and many other outlets.

If you want to join a breakthrough healthtech company and help accelerate its impact and growth, we encourage you to apply for this exciting opportunity!