Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market

Job Description

Roles and Responsibilities

• Provides regulatory strategy and direction to the business for Software as a Medical Device (SaMD), including cloud-hosted software, connected solutions, and AI/ML-based technologies, across product development, product launch, premarket submissions/registrations, and post-market compliance activities, working closely with global regulatory authorities.

• Supports regulatory planning and execution for global submissions and registrations (e.g., FDA, EU MDR/IVDR) and jointly with regional experts (e.g. UKCA, Health Canada, PMDA, and other global markets), ensuring alignment with evolving digital health and software regulatory frameworks.

• Develops specialized depth and/or breadth of expertise in regulatory requirements applicable to SaMD, including software lifecycle processes, cybersecurity, AI/ML considerations, and post-market surveillance. Serves as a best-practice and quality resource within the function.

• Maintains awareness of emerging regulatory trends, guidance, and standards impacting digital health, cloud-based software, and AI technologies, and contributes to regulatory strategy and policy development within the assigned area of responsibility.

• Acts as a skilled influencer, communicating complex regulatory concepts related to software and digital technologies to cross-functional stakeholders. Serves as a resource for colleagues with less experience and may lead small to moderate regulatory projects with defined risk and resource requirements.

• Explains complex or sensitive regulatory topics clearly, works to build consensus across functions, and applies developing persuasion skills to influence decisions within the regulatory and product development space.

• Impacts approaches, projects, and programs within the regulatory function and supported business organizations, contributing to quality, efficiency, and effectiveness of regulatory deliverables.

• Operates with moderate autonomy within broad policies and guidelines, exercising sound evaluative judgment in regulatory decision-making related to software technologies.

• Uses regulatory and technical expertise to analyze data, assess regulatory risk, and support recommendations. Leverages multiple internal and limited external sources outside of own function to arrive at well-reasoned regulatory decisions.

Required Qualifications

• Bachelor’s Degree in Scientific, Engineering, Computer Science, or related discipline, or a minimum of 8 years of relevant work experience.

• A minimum of 4 years of Regulatory Affairs and/or Quality Assurance experience.

• A minimum of 4 years of experience in the medical device, digital health, or pharmaceutical industry.

Desired Characteristics

• Experience with Software as a Medical Device (SaMD), digital health, cloud-based medical software, and/or AI/ML-enabled medical technologies.

• Understanding of regulatory frameworks and standards applicable to software and digital health (e.g., FDA SaMD guidance, EU MDR software rules, IEC 62304, ISO 14971, cybersecurity).

• Advanced degree in scientific, engineering, computer science, or regulatory affairs disciplines.

• Regulatory Affairs Certification (RAC).

• Experience managing regulatory activities and projects within global regulatory environments and working effectively across different cultures and regions.

• Excellent verbal and written communication and presentation skills, with the ability to communicate clearly and convincingly in English and tailor messaging to diverse stakeholders.

• Demonstrated understanding of the healthcare and digital health environment, including awareness of competitive, commercial, and regulatory trends impacting software and AI-based medical technologies.

• Ability to document, plan, and execute regulatory programs and projects; established project management skills.

• Demonstrated ability to analyze and resolve problems, assess regulatory risk, and support regulatory decision-making.

• Strong collaboration and leadership skills, with the ability to facilitate teamwork and influence without