Director of Regulatory Affairs - Remote

About the role

The Director of Regulatory Affairs will be a member of the Legal Team responsible for providing the enterprise with strategic counsel and support on regulatory and quality matters related to medical devices, including software and algorithms, and other digital health technologies. As a subject matter expert and leader, the Director of Regulatory Affairs will play a key role in developing and optimizing our regulatory affairs team, programs, and services.

Responsibilities

• Lead and draft, review, and provide guidance on regulatory product assessments and other deliverables
• Prepare regulatory plans/strategies and provide ongoing support as needed for various regulatory, quality, and compliance activities
• Provide expert and practical regulatory advice and support on regulatory and quality requirements throughout a project or product lifecycle
• Effectively communicate complex regulatory topics to a broad audience in our enterprise and collaborate across the enterprise to successfully strategize and achieve regulatory and quality objectives
• Review and provide guidance on labeling including promotional labeling and advertisements (promotional communications)
• Collecting, analyzing, and disseminating regulatory intelligence on new and changing requirements, policies, and guidelines
• Support regulatory compliance activities, including manufacturing site registration, audits, inspections, post-market vigilance reporting, and product recalls
• Prepare or support regulatory submissions and filings as needed
• Develop and present educational and training material covering medical device and digital health regulatory affairs topics
• Manage and participate in trade associations covering medical device topics and issues

Qualifications

• 10+ years of experience in medical device regulatory affairs or related field
• Proven experience in preparing and submitting regulatory documentation including filings to the FDA, EU MDR, and/or other global regulatory agencies
• Experience with completing or supporting regulatory compliance activities like site registrations, audits, post-market vigilance reporting, and product recalls
• Demonstrated familiarity using and/or managing electronic quality management systems
• Proven expertise and working knowledge of applicable regulations, standards and guidance for medical devices (FDA, QSMR, SaMD, ISO 13485, ISO 14971, IEC 62304, and other global regulatory requirements and quality standards)
• Proven excellent written and oral communication, interpersonal, and problem-solving skills to effectively interact with others, including cross-functional teams and regulatory agencies, and address regulatory matters
• Proven ability to learn and adapt to provide strategic regulatory advice in an evolving industry

Preferred Qualifications

• J.D., RAC Certification, ISO 13485 or other medical device auditor certification
• Direct experience with Software as a Medical Devices (SaMD), other Digital Health products, and accessories
• Direct experience with AI/ML-enabled medical devices or digital health technology

Pay and Benefits

The salary for this role will range from $134,600 to $230,800 annually based on full-time employment. We comply with all minimum wage laws as applicable.

We offer a comprehensive benefits package, incentive and recognition programs, equity stock purchase, and a 401k contribution (all benefits are subject to eligibility requirements).