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.
Supports regulatory planning and execution for global submissions and registrations (e.g., FDA, EU MDR/IVDR).
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.
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.

Requirements

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.
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 direct authority.
Ability to make sound business and regulatory judgments independently, while recognizing when to seek guidance and support.

Benefits

medical
dental
vision
paid time off
a 401(k) plan with employee and company contribution opportunities
life
disability
accident insurance
tuition reimbursement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategyregulatory planningregulatory submissionsregulatory requirementssoftware lifecycle processescybersecurityAI/ML technologiesdata analysisregulatory risk assessmentproject management

Soft Skills

communication skillsinfluencing skillsconsensus buildingproblem-solvingcollaborationleadershipautonomyevaluative judgmentteamworkpersuasion

Certifications

Bachelor's DegreeAdvanced DegreeRegulatory Affairs Certification (RAC)