Regulatory Affairs Manager – Digital Products
Job Description:
• 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
Apply Now
Apply Now
• 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
Apply Now
Apply Now