Principal Regulatory Affairs Specialist

Cleerly

4d•Remote

About The Position

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.

Requirements

Education: B.S. or higher degree in a Life Science, Engineering or related discipline.
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).
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.

Nice To Haves

Regulatory Affairs Certification (RAC) preferred.
Experience in supporting External 3rd Party Audits and Inspections preferred.

Responsibilities

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.
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.
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.
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.
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.