Manager, Regulatory Compliance

About the Opportunity We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Manager, Compliance must be a subject matter expert in compliance, encompassing domestic and international regulatory, quality, and related requirements. Responsible for proactively monitoring all relevant compliance changes and guiding the company to maintain adherence and achieve strategic success.. You'll be joining a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team and communicating daily with the product team. You will also be working daily with data scientists and medical doctors, who will help to integrate software solutions with the healthcare systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.   TTC: $170,000 - $179,000  *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.   Description:  The Manager, Compliance plays a key role in ensuring Cleerly's products, services, and operations meet global regulatory and quality requirements. This role requires in-depth knowledge of the medical device product development lifecycle, including design controls, safety and cybersecurity risk management, and usability engineering. Strong experience with Software as a Medical Device (SaMD) is essential, along with the technical depth and regulatory understanding to support compliance in a fast-paced, software-driven environment. This position requires a strong individual contributor and team collaborator who demonstrates critical thinking, problem-solving, and cross-functional coordination skills. The Manager, Compliance will work closely with functions across Quality, Regulatory, R&D, Operations, and Core Lab to promote a culture of compliance, continuous improvement, and audit readiness..   Key Responsibilities Ensure ongoing compliance of Cleerly's products, services, and operations with internal QMS processes and applicable global regulatory standards, including ISO 13485, 21 CFR Part 820, ISO 14971, IEC 62304, and EU MDR. Collaborate closely with Regulatory, Quality, Operations, Product Development, and Core Lab teams to align systems and processes that support compliance throughout the product lifecycle. Lead and participate in internal audits, proactively identifying risks and opportunities for improvement. Promote a state of continuous readiness ("always audit ready") across Cleerly's departments through training, awareness, and cross-functional collaboration. Serve as an interface for external audits and inspections (e.g., FDA, Notified Bodies, etc.), including planning, front- and back-room management, and response coordination. Lead and maintain Cleerly's MDSAP compliance program, and manage the relationship with the organization's Notified Body (BSI). Lead and/or support activities related to external audits by FDA, Notified Body, customers, and other international auditing bodies. This may include pre-audit logistics and requests, front and/or back room support during audits, and coordination of audit responses. Support and/or lead compliance activities related to field actions, recalls, and Quality Plans in response to changes or identified risks. Support Operations Quality by performing internal audits, mock inspections, and other proactive compliance activities. Contribute to the company's regulatory intelligence efforts by tracking and communicating changes to applicable regulations, standards, and best practices. Initiate, execute, and/or support Quality Plans and change control activities related to product, process, or system changes that may impact compliance, safety, or performance. Support the execution of Management Review, CAPA processes, and continuous improvement initiatives. Actively contribute to standards compliance by monitoring, interpreting, and applying evolving regulatory and industry standards to ensure Cleerly's practices remain current and aligned. Carry out additional responsibilities as assigned by the Sr./Director of Quality Systems and Regulatory Compliance.   Basic Qualifications Proven experience (10+ years) in healthcare technology, life sciences, or similar regulated industries, preferably with a focus on Software as a Medical Device (SaMD). Demonstrated experience supporting or leading external audits and regulatory inspections, including FDA, Notified Body, and MDSAP audits. Exceptional collaboration, problem-solving, critical-thinking, and decision-making skills. Strong organization and management skills, with the ability to prioritize, multi-task, and delegate to achieve established goals and objectives. Excellent interpersonal, communication, and presentation skills.   Technical Knowledge In-depth understanding of applicable standards, including ISO13485, ISO14971, IEC62304, and IEC62366. Knowledge of applicable regulations preferred: 21 CFR Part 820 US Quality Management System Regulation 2017/745 EU Medical Device Regulation In-depth understanding of Software as a Medical Device (SaMD) and software development lifecycles, including agile methods. Familiarity with technology applications, such as Jira, Confluence, Jama, Minitab, etc.   Supervisory Skills Minimum 5 years of technical leadership or people management experience in a quality or compliance role within a regulated industry. Proven track record in building and developing high-performing teams. Ability to work independently and proactively, while contributing effectively within a cross-functional team.   Education Requirements Bachelor's degree in a scientific or technical discipline required, or equivalent experience. Master's degree preferred. Certification as a Lead Auditor for ISO 13485 or MDSAP is highly desirable. Additional credentials such as ASQ certifications or Lean Six Sigma Black Belt are a plus. Experience with agile development and cloud solutions preferred. Location Requirement: This position is based in New York City and requires regular collaboration with our Core Lab teams in the US and Portugal. Travel to Portugal is required to support operations across both locations. You are expected to work in the New York City office daily. This also has 25% travel, with once a quarter travel to our Portugal office. 

Created: 2025-07-02