Head of Regulatory Affairs

December 4

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Pearl

WebsiteLinkedInAll Job Openings

Machine Learning • Dental Software • Artificial intelligence • Dental radiology • Pathology detection

51 - 200 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔥 Funding within the last year

💰 Series B on 2024-07

Description

• The Head of Regulatory Affairs will lead the regulatory strategy and operations to ensure compliance with all relevant regulatory requirements. • Develop and implement regulatory strategies to ensure compliance with FDA, MDR, and other global regulatory requirements for AI-driven SaMD. • Build and lead a high-performing regulatory affairs team, fostering a culture of compliance and continuous improvement. • Collaborate with cross-functional teams to integrate regulatory requirements into product development processes. • Apply in-depth knowledge of AI technologies and their regulatory implications to guide the development and approval of AI-driven medical devices. • Lead the preparation, submission, and negotiation of regulatory documents, ensuring timely and successful approvals. • Implement robust risk management practices to identify and mitigate regulatory risks. • Represent the company in external regulatory forums and industry associations.

Requirements

• 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.

Benefits

• Competitive Benefit and Compensation Offerings • Ongoing Training and Development Opportunities • Unaccrued, Flexible PTO • Remote Work