Senior Analyst, Regulatory Affairs
On-siteBengaluru, Karnataka, India or Kolkata, West Bengal, India
Job Summary
Monitor and track global regulatory developments affecting IVDs, medical devices, software, AI-enabled products, and chemical/environmental compliance frameworks. Perform regulatory intelligence assessments and summarize regulatory changes, identifying potential impacts to products, processes, systems, and documentation. Maintain regulatory intelligence databases, dashboards, trackers, and communication tools. Prepare regulatory impact assessments and support regulatory change management activities, including tracking actions, maintaining compliance plans, and facilitating implementation with cross-functional stakeholders. Develop and deliver periodic regulatory intelligence reports and presentations for management review. Leverage digital and AI-enabled tools to improve regulatory monitoring, trend analysis, and knowledge management processes. Support inspections, audits, and compliance initiatives by providing regulatory intelligence and change management documentation. This role reports to the Senior Manager, Regulatory Affairs within the Global Quality & Regulatory Affairs organization.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field
- 5+ years of experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related functions within the medical device or IVD industry
- Working knowledge of global medical device and IVD regulations, including FDA regulations, EU IVDR, ISO 13485, and applicable regulatory guidance
- Experience conducting regulatory assessments and translating regulatory requirements into actionable business recommendations and managing or supporting compliance-related projects in a cross-functional environment
- Strong analytical, communication, and project management skills
- Experience using regulatory intelligence platforms, compliance databases, or digital tools
Desired Qualifications
- Master's degree preferred
- Experience with AI/software regulations, cybersecurity regulations, or chemical/environmental compliance requirements
- Experience supporting audits, inspections, or interactions with regulatory authorities and notified bodies
- Experience leveraging AI or automation tools to improve regulatory intelligence workflows
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