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Head of Regulatory and Quality

Overjet

Overjet

Legal, Quality Assurance
Boston, MA, USA · Remote
Posted on Wednesday, June 28, 2023

Overjet is on a mission to improve oral health for all.

Our cutting-edge artificial intelligence technology encodes dentist-level training and analysis into scalable software tools. Today, our flagship products are used by some of the country’s largest insurance companies, dental support organizations, and dental practices to enable the best patient care.

We’re building an ambitious team of data scientists, software engineers, clinicians, and business thinkers and doers.

Overjet is backed by an amazing consortium of Venture Capital including General Catalyst, Insight Partners, Crosslink Capital and the E14 Fund. The company has raised nearly $80 million in capital to accelerate talent acquisition and product development driven by strong demand for Overjet’s dental AI.

The Role

We're looking for a Director of Regulatory Affairs and Quality Assurance. This role is a unique opportunity to lead and build Overjet’s Regulatory Affairs + Quality Assurance teams. We're looking for a regulatory affairs medical device professional with at least 7 years of experience, of which at least 2 years are in the Software Medical Device industry. It is important that you have had extensive experience in direct interactions with the US Food and Drug Administration. In this role, you will also provide strategic input during the product creation process and contribute to the company's overall regulatory and product strategy plan.

Responsibilities:

  • Develop and implement quality and regulatory strategies.
  • Together with your team, own regulatory submission efforts (e.g. pre-submissions, 510(k)s, de Novo's, Product Reports/Supplements).
  • Lead our engagement with the FDA and other international regulatory bodies.
  • Oversee the ISO 13485 and MDSAP-certified quality management system as the Management Representative.
  • Support engineering, machine learning, and product teams throughout the design control process.
  • Drafting and curating all relevant documentation.
  • Coach and mentor a world-class quality and regulatory team.

Qualifications:

  • Significant experience in regulatory approval processes related to medical devices with increasing levels of responsibility, with at least 2 years related to software as a medical device (SaMD).
  • Direct interactions and experience managing medical device approval processes with the FDA, EU Notified Bodies, and other global regulatory bodies.
  • Advanced knowledge of the requirements of ISO 13485:2016, regulations of the MDSAP regions and the EU MDR is preferred but not required.
  • Experience building and managing quality programs for regulated medical devices, including implementing and maintaining a QMS.
  • Knowledge and comfort interpreting statistical analysis required for regulatory submissions.
  • Ability to thrive in a fast-paced, technical, and mission-focused environment.

Why Overjet?

  • Competitive Compensation and Equity
  • Fully Remote Working Policy for US Based Employees
  • 401k plans with a matching program
  • Medical, Dental and Vision coverage: 99% employee premium covered, 75% dependent premium covered
  • Life and AD+D Insurance
  • 8 weeks Paid Parental Leave
  • Optional HSA with Employer contribution
  • Flexible PTO policy and company-paid holidays
  • Annual Learning and Development Stipend
  • Work from Home Stipend

Company Recognition

  • 2022 AI-50 Forbes
  • 2022 22 Start-ups to Watch in 2022 - Built in Boston
  • 2021 AI 100 Ranking, showcasing the 100 most promising private artificial intelligence companies in the world - CB Insights
  • 2021 Digital Health 150, highlighting the 150 most promising private digital health companies in the world - CB Insights
  • 2020 & 2019 Digital Health 150 - CB Insights

EEOC

Overjet 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. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. Even if you don't meet 100% of the qualifications for this job, we strongly encourage you to apply!

If you are a Colorado resident: Please contact us by emailing recruiting@overjet.ai to receive compensation and benefits information for this role. Please include the job title in the subject line of the email.

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