Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Responsibilities

• Develop and lead global regulatory strategies for precision medicine and digital health
• Identify regulatory requirements and provide guidance to project teams
• Collaborate with regulatory representatives for lifecycle management activities
• Ensure regulatory plans accommodate precision medicine approaches
• Communicate developments impacting regulatory success to management
• Anticipate risks and develop solutions
• Represent Global Regulatory Affairs in senior level interactions
• Participate in cross-functional initiatives and tasks
• Train cross-functional teams on regulatory processes
• Promote continuous improvement and best practices in regulatory function
• Support regulatory strategy for licensing opportunities
• Monitor trends affecting regulatory environments

Qualifications

• Bachelor's Degree in scientific discipline preferred
• Advanced degree (PhD, M.D., PharmD, MS) preferred
• 5+ years in regulatory affairs, particularly with medical devices or diagnostics
• Track record in regulatory strategies for digital health and precision medicine
• Expertise in device development regulations and biomarker strategies
• Experience with global health authority interactions, including FDA and EMA
• Strong verbal and written communication skills, with complex regulatory concept translation

Benefits

• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays and well-being benefits
• Up to 80 hours of sick time annually
• Accrual of up to 120 hours of paid vacation for new hires

Pay

$154,400 – $242,550 annually

Schedule

Remote - US based candidates only, no visa sponsorship available