About Pearl
Pearl is shaping the future of dentistry with a suite of AI solutions developed to establish higher standards of quality and care for patients worldwide.
Since 2019, our team has engineered FDA-cleared computer vision capabilities for interpretation of 2D and 3D dental imagery industry-leading capabilities which clinicians, practice owners, labs and insurers use to elevate the efficiency, accuracy and consistency of dental care around the world.
Who We're Looking For
The Head of Regulatory Affairs will lead the regulatory strategy and operations to ensure compliance with all relevant regulatory requirements, specifically focusing on FDA and Medical Device Regulation (MDR) as applied to Software as a Medical Device (SaMD).
The ideal candidate has experience in AI-driven medical technologies and is capable of navigating the complex regulatory landscape to ensure successful product approvals.
Regulatory Strategy and Compliance :
- Develop and implement regulatory strategies to ensure compliance with FDA, MDR, and other global regulatory requirements for AI-driven SaMD.
- Monitor and interpret regulatory developments and trends, advising the executive team on potential impacts.
- Lead regulatory submissions and interactions with regulatory bodies, including pre-submissions, IDEs, 510(k)s, PMAs, and CE mark applications.
Leadership and Management :
- Build and lead a high-performing regulatory affairs team, fostering a culture of compliance and continuous improvement.
- Provide strategic direction and mentorship to regulatory affairs staff, ensuring alignment with organizational goals.
Product Development and Lifecycle Management :
- Collaborate with cross-functional teams, including R&D, Quality, Clinical, and Marketing, to integrate regulatory requirements into product development processes.
- Ensure regulatory compliance throughout the product lifecycle, from concept through commercialization and post-market activities.
AI and SaMD Expertise :
- Apply in-depth knowledge of AI technologies and their regulatory implications to guide the development and approval of AI-driven medical devices.
- Stay abreast of emerging regulations and guidance related to AI and SaMD, ensuring proactive compliance and competitive advantage.
Regulatory Submissions and Approvals :
- Lead the preparation, submission, and negotiation of regulatory documents, ensuring timely and successful approvals.
- Coordinate with regulatory authorities, including the FDA and European regulatory bodies, to facilitate the approval process.
Risk Management and Quality Assurance :
- Implement robust risk management practices to identify and mitigate regulatory risks.
- Ensure alignment with quality management systems (QMS) and regulatory standards, such as ISO 13485 and ISO 14971.
Stakeholder Engagement :
- Represent the company in external regulatory forums and industry associations, advocating for favorable regulatory environments for AI-driven medical devices.
- Communicate regulatory requirements and strategies effectively to internal and external stakeholders, including senior management, investors, and partners.
What You'll Need to Succeed
- Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs). Advanced degree preferred.
- Minimum of 10 years of regulatory affairs experience in the medical device industry, with a strong focus on FDA and SaMD.
- Proven track record of successful regulatory submissions and approvals for AI-driven medical technologies.
- In-depth knowledge of AI and its application in medical devices, including regulatory implications and compliance strategies.
- Strong leadership and team management skills, with the ability to inspire and guide a diverse team.
- Excellent communication and negotiation skills, with the ability to interact effectively with regulatory authorities and cross-functional teams.
- Certification in regulatory affairs (e.g. RAC) is highly desirable.
- Experience with MDR preferred.
What We Offer
- Competitive Benefit and Compensation Offerings
- Ongoing Training and Development Opportunities
- Unaccrued, Flexible PTO
- Remote Work
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