Principal Regulatory Affairs Specialist

About the Opportunity:

Cleerly is seeking a Principal Regulatory Affairs Specialist to support and execute global regulatory strategies for innovative AI/ML-enabled medical devices. This role plays a key part in guiding products from early development through global market authorization and ongoing regulatory compliance.

As a Principal Regulatory Affairs Specialist, you will collaborate cross-functionally with Product, Engineering, Clinical, and Quality teams to ensure regulatory requirements are integrated into product development plans and submission strategies. You will prepare and manage regulatory submissions across multiple regions (including the U.S., Europe, Canada, and other international markets), support interactions with regulatory authorities, and ensure alignment with evolving global requirements for Software as a Medical Device (SaMD) and AI/ML-based technologies.

This role is well-suited for a regulatory professional who combines strong technical writing and submission experience with the ability to provide practical regulatory guidance to product teams. You will contribute meaningfully to regulatory strategy execution while helping ensure innovative technologies reach patients in a compliant and efficient manner.  

About the Team:

The Regulatory Affairs team at Cleerly partners closely with cross-functional stakeholders to enable the successful development and commercialization of AI-driven medical technologies. We work collaboratively with Clinical, Engineering, Data Science, Product, and Quality teams to ensure regulatory requirements are clearly understood, strategically applied, and effectively executed.

Our team is focused on operational excellence by delivering high-quality global submissions, maintaining regulatory compliance, and proactively monitoring changes in the regulatory landscape, particularly for AI/ML and SaMD technologies. We value accountability, clarity, and collaboration, and we foster an environment where regulatory professionals are empowered to take ownership of submissions and provide thoughtful guidance to project teams.

As part of a growing organization at the forefront of cardiovascular AI innovation, the Regulatory Affairs team plays an essential role in bringing transformative technologies to market responsibly and efficiently.

Responsibilities:

Regulatory Strategy & Submissions

• Define and execute regulatory strategies for AI/ML-enabled medical devices across global markets (e.g., U.S., EU, Canada, APAC), ensuring alignment with applicable regulations and standards. 
• Prepare, review, and complete regulatory submissions to global regulatory authorities (e.g., FDA 510(k), De Novo, CE Mark, Health Canada), ensuring documentation meets quality and compliance standards. 
• Serve as a primary regulatory representative on assigned projects, supporting interactions with regulatory authorities during submission preparation and review.
• Independently coordinate cross-functional teams to ensure timely preparation, compilation, submission, and lifecycle management of regulatory documentation.

Regulatory Guidance & Product Development Support

• Provide regulatory guidance to Product, Engineering, Clinical, Data Science, and Quality teams throughout the product development lifecycle.
• Independently determine regulatory requirements for intended products and markets, advising on appropriate submission pathways and approval strategies.
• Evaluate product changes for regulatory impact and provide clear recommendations regarding global filing requirements and compliance obligations.
• Ensure regulatory considerations are integrated into product development plans, risk management activities, and design control processes.

Global Regulatory Compliance & Lifecycle Management

• Ensure medical devices are developed and maintained in compliance with global regulatory standards and current state-of-the-art practices, particularly for Software as a Medical Device (SaMD) and AI/ML technologies.
• Support post-market regulatory activities, including regulatory reporting, vigilance/adverse event reporting (as applicable), license renewals, registrations, and product updates.
• Organize and maintain regulatory documentation to support inspections, audits, and global market access.

Regulatory Intelligence & Policy Monitoring

• Monitor proposed and final regulations, guidance documents, and industry trends related to AI/ML and SaMD.
• Assess regulatory changes for potential impact on products, internal procedures, and regulatory strategies, and communicate recommendations to cross-functional stakeholders.

Collaboration, Compliance & Continuous Improvement

• Coordinate internal peer reviews of regulatory submissions to ensure accuracy, completeness, and consistency.
• Identify potential compliance gaps and proactively recommend solutions or process improvements.
• Contribute to the development and maintenance of Regulatory Affairs procedures, templates, and best practices.
• Provide mentorship and guidance to junior and mid-level regulatory professionals on submission processes and regulatory requirements.

Perform other duties as required to support the effective functioning of the Regulatory Affairs department.

Requirements 

• Education: B.S. or higher degree in a Life Science, Engineering or related discipline.
• Regulatory Affairs Certification (RAC) preferred.

• Experience: 

• Minimum 7 years of medical device experience in a regulatory affairs role.
• Minium 3 years’ experience directly related to AI/ML-based medical devices or software as a medical device (SAMD) preferred
• Experience in global regulatory submittals and applications for medical devices (AI/ML SaMD preferred).
• Experience in supporting External 3rd Party Audits and Inspections preferred.
• 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.

Compensation: 

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a XX% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $170,000 - $190,000
• TTC: $195,500 - $218,500

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.