13 Aug
|
Jobgether
|
India
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Analyst, Regulatory Affairs based in India.
This role supports global regulatory intelligence and regulatory change management across a highly regulated life sciences workplace. You will monitor evolving requirements and assess how they may affect products, processes, systems, and documentation. The position offers broad exposure to medical devices, IVDs, software, AI-enabled products, and chemical and environmental compliance frameworks. You will translate complex regulatory developments into practical recommendations and coordinated compliance actions. Working closely with cross-functional teams, you will help reduce regulatory risk, business disruption, and commercialization delays. The role also provides opportunities to leverage digital and AI-enabled tools to modernize regulatory intelligence and knowledge management.
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Accountabilities:
Monitor and track global regulatory developments affecting IVDs, medical devices, software,
AI-enabled products, and chemical/environmental compliance frameworks, including FDA, EU IVDR, REACH, RoHS, CLP, PFAS, and EPA requirements.
Conduct regulatory intelligence assessments and translate regulatory changes into clear summaries of potential impacts on products, processes, systems, and documentation.
Maintain regulatory intelligence databases, dashboards, trackers, and communication tools to ensure regulatory information remains accurate, accessible, and actionable.
Prepare regulatory impact assessments and support regulatory change management activities, including action tracking, compliance plans, and implementation activities.
Collaborate with cross-functional stakeholders to coordinate timely responses to regulatory changes and ensure appropriate compliance actions are implemented.
Develop and deliver periodic regulatory intelligence reports, presentations, and management updates to c
📌 Senior Analyst, Regulatory Affairs (India)
🏢 Jobgether
📍 India