About the Opportunity

As Senior Manager, Regulatory Affairs, you will oversee regulatory activities and personnel to support Cleerly’s product development, global market access and compliance objectives. You will help contribute to Cleerly’s regulatory team in the areas of regulatory strategy, regulatory intelligence, and regulatory operations including submissions.

You will build a team of regulatory professionals, ensuring high-quality execution of Cleerly’s regulatory strategy, submissions; provide guidance to cross-functional teams, and adherence to evolving global regulatory requirements. This role combines hands-on regulatory expertise with leadership responsibilities, contributing to departmental strategy and talent development.  

You will support inspections and/or audits from health authorities, support and/or lead global regulatory and compliance initiatives and provide regulatory and compliance guidance while helping to develop, lead and manage the regulatory team.

Responsibilities

Digital Health & SaMD Regulatory Leadership

• Lead the regulatory strategy for Cleerly's AI and Software as a Medical Device (SaMD). This includes authoring and managing submissions for key markets (e.g., FDA 510(k), De Novo; EU CE Marking under MDR).
• You will serve as the subject matter expert on SaMD regulations, ensuring our AI/ML-powered products meet and exceed global standards for safety, efficacy, and cybersecurity.

Advanced Imaging & Technology Compliance

• Collaborate closely with R&D and product teams to ensure regulatory requirements are integrated into the design and development of our Cleerly’s software and AI medical devices.
•  Provide guidance on verification and validation activities, clinical data requirements, and usability engineering to support our product claims and intended use.

Proactive Regulatory Intelligence

• Develop and maintain a robust regulatory intelligence program to monitor, analyze, and communicate changes in the global regulatory environment.
• You will translate new regulations, guidance documents, and standards into actionable strategies, ensuring Cleerly stays ahead of the curve in areas like AI/ML transparency, data privacy, and interoperability.

Advertising & Promotional Governance

• Establish and manage the Ad Promo review process to ensure all commercial and marketing materials are compliant, truthful, and non-misleading.
• You will work cross-functionally with commercial teams to substantiate claims and align promotional activities with cleared/approved product labeling, mitigating compliance risk.

Scalable Process Management

• Drive the optimization of regulatory workflows and information systems. This includes refining submission templates, managing regulatory documentation within the Quality Management System (QMS), and implementing efficient process management tools.
• Your goal is to build a scalable and agile regulatory operations framework that supports rapid innovation.

End-to-End Regulatory Compliance:

• Champion a culture of regulatory compliance throughout the organization.
• Your expertise will be crucial during internal and external audits (e.g., FDA inspections, Notified Body audits), ensuring our operations are consistently inspection-ready.

People Leadership & Team Management:

•  Manage and mentor regulatory staff, providing coaching, feedback, and professional development.
• Delegate responsibilities effectively, balancing oversight with empowerment of team members.
• Conduct performance reviews and contribute to talent management practices.

Other Responsibilities

• Maintain knowledge of industry trends, regulatory changes, and emerging best practices by reviewing relevant resources regularly.
• Contribute to the development and maintenance of Regulatory Affairs working practices and Standard Operating Procedures.
• Performs other duties as required or assigned to enable effective functioning of the Regulatory Affairs department.

Requirements 

• Minimum 10 years of medical device experience in a regulatory affairs role required.
• Minimum 5 years’ experience directly related to AI/ML-based medical devices or software as a medical device (SAMD).
•  Minimum 5 years’ direct people management experience preferred (e.g., leading individual contributors or project teams) preferred.
• Experience in global regulatory submittals and applications for medical devices required (AI/ML SaMD preferred).
• Experience in supporting External 3rd Party Audits and Inspections required.
• Education: B.S. or higher degree in a Life Science, Engineering or related discipline.
• Regulatory Affairs Certification (RAC) preferred.
• Demonstrated experience in developing regulatory strategy for novel software (SaMD) or AI/ML-driven medical devices is required."
• Experience with the De Novo classification process and/or Breakthrough Device Designation program is highly desirable."
• Proven ability to collaborate with and influence cross-functional technical teams (e.g., data science, engineering) to achieve regulatory objectives
• Demonstrated knowledge and experience in the identification and interpretation of global regulations, guidelines, and compliance. Must be able to independently coordinate and oversee interdisciplinary project team in quality and timely delivery and compilation and retention of submission documents.
• Excellent organizational, writing and verbal communication skills.

Salary*: $230,000 - $253,000

 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.