Senior Analyst, Regulatory Affairs

📋 Description

• Monitor and track global regulatory developments affecting IVDs, medical devices, software
• Conduct regulatory intelligence assessments and translate changes into actionable impacts on
• Maintain regulatory intelligence databases, dashboards, trackers, and communication tools.
• Prepare regulatory impact assessments and support change management activities (action tracking
• Collaborate with cross-functional stakeholders to coordinate timely responses to regulatory changes.
• Develop and deliver regulatory intelligence reports, presentations, and management updates.

🎯 Requirements

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field; Master’s
• 5+ years in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related within
• Working knowledge of global medical device and IVD regulations (FDA, EU IVDR, ISO 13485).
• Experience translating regulatory requirements into actionable recommendations for business/tech
• Experience managing or supporting cross-functional compliance projects.
• Strong analytical and communication skills; ability to prepare clear reports/presentations.

🎁 Benefits

• Comprehensive health care and employee benefits for well-being.
• Paid time off and work-life balance programs.
• Professional development and career growth in a global life sciences environment.
• Exposure to global regulatory programs across medical devices, IVDs, software, AI, and
• Chance to work with digital/AI-enabled tools to modernize regulatory processes.
• Flexible working arrangements may be available for eligible roles.