Director of Regulatory Affairs – AVS Digital

Role Overview

• Provides high quality regulatory advice and is seen as a valued strategic partner to the business they support
• Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the business
• Provides deep domain expertise in regulatory areas critical to the Digital subsegment of the AVS business including Software Lifecycle processes, Software in or as a Medical Device, Artificial Intelligence/Machine Learning, Cybersecurity
• 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
• Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering/R&D/Clinical and submits premarket submissions to regulatory authorities, as per business timelines
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements
• Supports and encourages a collaborative, inclusive, open and team based culture across their organization and the larger Regulatory Affairs organization and in particular the Digital Regulatory Affairs team
• Seeks out and implements proactive initiatives to improve and enhance the regulatory compliance and efficiency for the team and opportunities to learn in new scientific or technical areas important to the business

Requirements

• Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years work experience
• A minimum of 7 years Regulatory Affairs / Quality Assurance experience
• A minimum of 7 years' experience in the medical device or pharmaceutical industry
• A minimum of 2 years experience of people management, project management, and regulatory agency interactions
• Advanced degree in scientific, engineering, computer science, or regulatory affairs disciplines (desired)
• Experience with Software as a Medical Device (SaMD), digital health, cloud-based medical software, and/or AI/ML-enabled medical technologies (desired)
• 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) (desired)
• Experience managing regulatory activities and projects within global regulatory environments and working effectively across different cultures and regions (desired)
• Excellent verbal and written communication and presentation skills, with the ability to communicate clearly and convincingly in English and tailor messaging to diverse stakeholders (desired)
• Demonstrated ability to analyze and resolve problems, assess regulatory risk, and support regulatory decision-making (desired)
• Strong collaboration and leadership skills, with the ability to facilitate teamwork and influence (desired)
• Ability to make sound business and regulatory judgments independently, while recognizing when to seek guidance and support (desired)

Tech Stack

• Cloud
• Cyber Security

Benefits

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