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QA/RA Specialist, Regulatory

VideaHealth

VideaHealth

Legal, Quality Assurance
Boston, MA, USA
Posted on Saturday, December 17, 2022
Our Mission:
VideaHealth is on a mission to improve the lives of billions of people around the globe by bringing Artificial Intelligence powered tools to the world of dentistry.
About Us:
Spun out of MIT, we are a team of business operators, engineers, AI scientists, and clinicians bringing AI-powered software to dentists and insurances. VideaHealth’s solutions are already used by many leading Dental Chains and Insurers to improve the quality of care through better diagnoses, lower operating costs, and improved patient understanding. We are supported by some of the best investors in the world, having raised over $26M in Venture Capital from Tier 1 investors such as Spark Capital (Twitter, SnapChat, SmileDirectClub), Zetta Venture (Kaggle) and Pillar VC (PathAI), 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. We are looking for ambitious and collaborative self-starters to join us in making an impact on this world!
About this Position:
As the 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 eQMS modules. You will drive cybersecurity management certification projects.
You will support 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 be used for institutional review board (IRB) 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!

Requirements

  • Bachelor’s Degree.
  • Minimum of 3 years’ experience. Additional years is a plus.
  • Certification(s) or credential(s) for quality auditing, regulatory affairs, software quality assurance, or cybersecurity is a plus.
  • Strong communication and collaboration mindset with external and internal 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 or external QMS audits. Lead auditor experience is a plus.
  • Experience cybersecurity and electronic personal health information (ePHI) process comprehension is a plus. This includes working knowledge of HITRUST, SOC2, HIPAA, or GDPR.
  • Experience with SaMD testing processes is a plus.
  • Experience implementing internal business systems (eQMS, cybersecurity framework management software, etc.) is a plus.
  • Experience with medical device premarket clearance submissions (USA FDA 510(K), EU MDR, others internationally) is a plus.

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 and business differentiators.
  • Adaptable and creative approach to problem solving.
  • A sense of curiosity and interest in Machine Learning.
Our Company Values
Mission-Driven:
• We are ambitious in our mission. We want to bring better health to millions of people globally by changing dentistry through AI.
• This is more than a job: We are motivated by our responsibility to patients and customers.
We are selfless in the pursuit of our collective mission, balancing and prioritizing company goals ahead of individual goals when necessary to ensure company success.
• We adapt, persevere, and finesse our way through roadblocks and find a way to continue moving forward.
Championship Team Mentality:
• We support each other on our journey forward, and actively look for ways to collaborate and learn from each other to help our customers overcome their challenges while building an exceptional team and productive environment.
• Feedback is a gift: We motivate each other to do our best work and give, receive and welcome constructive feedback with positive intent.
• We are drivers and not passengers: Regardless of our job descriptions we observe what needs to be done and spring to action.
• We celebrate our successes and learn from our mistakes as a team.
Strive for Excellence:
• We strive for excellence in what we do: We act with a sense of urgency, with high standards, and constantly learn.
• We have a sense of urgency. If something can benefit from action now, it should be done promptly
• We keep ourselves to a high standard of working smart, perfecting our craft, and driving hard while balancing this out for individual long-term resilience.
• We have a growth mindset as individuals and as a team, we think about how can we do something better or faster and how can we learn.
Pay Range: $65,000 - $200,000