Cleerly
Overview
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Senior Manager, Regulatory Affairs
role at
Cleerly About Cleerly – a healthcare company revolutionizing how heart disease is diagnosed, treated, and tracked. Founded in 2017 by a leading cardiologist, Cleerly is a growing team of engineering, operations, medical affairs, marketing, and sales leaders. The company has raised substantial funding to support rapid growth and its mission. Most teams work remotely with access to offices in Denver, CO; New York, NY; Dallas, TX; and Lisbon, Portugal, with some roles requiring on-site presence. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions aimed at preventing heart attacks. Our technology enables comprehensive quantification and characterization of atherosclerosis in heart arteries, supported by extensive clinical trial experience. We collaborate digitally using Google Workspace, Slack, Confluence/Jira, and Zoom; role-specific technology needs may vary and will be listed in the job description. Travel is required for some roles, typically once per month or per quarter; for some roles (e.g., sales or external facing), travel could be up to 90% of the time. 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 contribute to regulatory strategy, regulatory intelligence, and regulatory operations including submissions. You will build and lead a team of regulatory professionals, ensure high-quality execution of regulatory strategy and submissions, provide guidance to cross-functional teams, and ensure 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 audits from health authorities, lead global regulatory and compliance initiatives, and provide regulatory and compliance guidance while developing and managing the regulatory team. Responsibilities
Lead the regulatory strategy for Cleerly’s AI and Software as a Medical Device (SaMD), including authoring and managing submissions for key markets (e.g., FDA 510(k), De Novo; EU CE Marking under MDR). Serve as the subject matter expert on SaMD regulations, ensuring AI/ML-powered products meet global standards for safety, efficacy, and cybersecurity. Collaborate with R&D and product teams to integrate regulatory requirements into design and development of software and AI medical devices. Provide guidance on verification and validation activities, clinical data requirements, and usability engineering to support product claims and intended use. Develop and maintain a robust regulatory intelligence program to monitor and analyze changes in the global regulatory environment. Translate new regulations, guidance documents, and standards into actionable strategies, ensuring readiness in AI/ML transparency, data privacy, and interoperability. Establish and manage the Ad Promo review process to ensure marketing materials are compliant, truthful, and non-misleading. Work cross-functionally with commercial teams to substantiate claims and align promotional activities with cleared product labeling, mitigating compliance risk. Drive optimization of regulatory workflows and information systems, refine submission templates, and manage regulatory documentation within the QMS. Build a scalable regulatory operations framework to support rapid innovation. Champion a culture of regulatory compliance and support internal and external audits (e.g., FDA inspections, Notified Body audits). Manage and mentor regulatory staff, provide coaching and development, delegate responsibly, and conduct performance reviews. Requirements
Minimum 10 years of medical device experience in a regulatory affairs role. Minimum 5 years’ experience related to AI/ML-based medical devices or software as a medical device (SaMD). Minimum 5 years’ direct people management experience (preferred). Experience in global regulatory submittals and applications for medical devices (AI/ML SaMD preferred). Experience supporting external third-party audits and inspections. B.S. or higher in Life Science, Engineering, or related discipline. Regulatory Affairs Certification (RAC) preferred. Experience developing regulatory strategy for novel software (SaMD) or AI/ML-driven devices is required. Desirable: experience with De Novo classification and/or Breakthrough Device Designation. Proven ability to collaborate with cross-functional teams to achieve regulatory objectives. Strong knowledge of global regulations, guidelines, and compliance; ability to coordinate interdisciplinary project teams and submission documentation. Excellent organizational, writing, and verbal communication skills. Salary : $230,000 - $253,000 Working at Cleerly takes HEART. Discover our Core Values:
Humility, Excellence, Accountability, Remarkable, Teamwork. We value diverse experiences and encourage applications even if you do not meet 100% of the qualifications. Job duties and responsibilities are subject to change. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER.
We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. You can STOP messaging by sending STOP. For more information see our Privacy Policy. All official emails will come from @cleerlyhealth.com email accounts.
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Join to apply for the
Senior Manager, Regulatory Affairs
role at
Cleerly About Cleerly – a healthcare company revolutionizing how heart disease is diagnosed, treated, and tracked. Founded in 2017 by a leading cardiologist, Cleerly is a growing team of engineering, operations, medical affairs, marketing, and sales leaders. The company has raised substantial funding to support rapid growth and its mission. Most teams work remotely with access to offices in Denver, CO; New York, NY; Dallas, TX; and Lisbon, Portugal, with some roles requiring on-site presence. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions aimed at preventing heart attacks. Our technology enables comprehensive quantification and characterization of atherosclerosis in heart arteries, supported by extensive clinical trial experience. We collaborate digitally using Google Workspace, Slack, Confluence/Jira, and Zoom; role-specific technology needs may vary and will be listed in the job description. Travel is required for some roles, typically once per month or per quarter; for some roles (e.g., sales or external facing), travel could be up to 90% of the time. 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 contribute to regulatory strategy, regulatory intelligence, and regulatory operations including submissions. You will build and lead a team of regulatory professionals, ensure high-quality execution of regulatory strategy and submissions, provide guidance to cross-functional teams, and ensure 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 audits from health authorities, lead global regulatory and compliance initiatives, and provide regulatory and compliance guidance while developing and managing the regulatory team. Responsibilities
Lead the regulatory strategy for Cleerly’s AI and Software as a Medical Device (SaMD), including authoring and managing submissions for key markets (e.g., FDA 510(k), De Novo; EU CE Marking under MDR). Serve as the subject matter expert on SaMD regulations, ensuring AI/ML-powered products meet global standards for safety, efficacy, and cybersecurity. Collaborate with R&D and product teams to integrate regulatory requirements into design and development of software and AI medical devices. Provide guidance on verification and validation activities, clinical data requirements, and usability engineering to support product claims and intended use. Develop and maintain a robust regulatory intelligence program to monitor and analyze changes in the global regulatory environment. Translate new regulations, guidance documents, and standards into actionable strategies, ensuring readiness in AI/ML transparency, data privacy, and interoperability. Establish and manage the Ad Promo review process to ensure marketing materials are compliant, truthful, and non-misleading. Work cross-functionally with commercial teams to substantiate claims and align promotional activities with cleared product labeling, mitigating compliance risk. Drive optimization of regulatory workflows and information systems, refine submission templates, and manage regulatory documentation within the QMS. Build a scalable regulatory operations framework to support rapid innovation. Champion a culture of regulatory compliance and support internal and external audits (e.g., FDA inspections, Notified Body audits). Manage and mentor regulatory staff, provide coaching and development, delegate responsibly, and conduct performance reviews. Requirements
Minimum 10 years of medical device experience in a regulatory affairs role. Minimum 5 years’ experience related to AI/ML-based medical devices or software as a medical device (SaMD). Minimum 5 years’ direct people management experience (preferred). Experience in global regulatory submittals and applications for medical devices (AI/ML SaMD preferred). Experience supporting external third-party audits and inspections. B.S. or higher in Life Science, Engineering, or related discipline. Regulatory Affairs Certification (RAC) preferred. Experience developing regulatory strategy for novel software (SaMD) or AI/ML-driven devices is required. Desirable: experience with De Novo classification and/or Breakthrough Device Designation. Proven ability to collaborate with cross-functional teams to achieve regulatory objectives. Strong knowledge of global regulations, guidelines, and compliance; ability to coordinate interdisciplinary project teams and submission documentation. Excellent organizational, writing, and verbal communication skills. Salary : $230,000 - $253,000 Working at Cleerly takes HEART. Discover our Core Values:
Humility, Excellence, Accountability, Remarkable, Teamwork. We value diverse experiences and encourage applications even if you do not meet 100% of the qualifications. Job duties and responsibilities are subject to change. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER.
We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. You can STOP messaging by sending STOP. For more information see our Privacy Policy. All official emails will come from @cleerlyhealth.com email accounts.
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