Overjet is on a mission to improve oral healthcare 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 looking for a Director of Regulatory Affairs. This role is a unique opportunity to lead and build Overjet’s Regulatory Affairs 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.
- Develop and implement regulatory strategy and roadmaps through a deep understanding of the regulatory landscape
- Responsible for the planning, coordination, preparation, and completion of document packages for regulatory submissions (e.g. pre-submissions, 510(k)s, de Novo's, Product Reports/Supplements, ISO 27001)
- Lead meetings and correspondences with the Food and Drug Administration and other international regulatory bodies for approvals and ongoing reporting
- Develop and direct the regulatory strategy for medical device compliance and quality management
- Stay informed regarding new guidelines and regulations for successful implementation in the QMS
- Help engineering, manufacturing, and clinical teams throughout the design control process; offering regulatory expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing, including review of design documentation to meet regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provide guidance to the team on risk assessment and required corrective actions to meet regulatory requirements
- Hire and develop a world class team to deliver regulatory compliance
- 7+ years of regulatory approval processes related to medical devices, with at least 2 years related to software as a medical device (SaMD)
- Direct interactions and experience managing medical device approval processes with the Food and Drug Administration, EU Notified Bodies, and other global regulators
- Experience building and managing quality programs for regulated medical devices
- Knowledge and comfort interpreting statistical analysis required in clinical trials
- Familiarity with relevant regulatory requirements and guidance documents
- Strong project management and ownership of results