Job Description
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 environment. 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.
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 communicate emerging requirements, trends, risks, and recommended actions.
- Leverage digital and AI-enabled technologies to improve regulatory monitoring, trend analysis, reporting, and knowledge management processes.
- Support regulatory inspections, audits, and broader compliance initiatives by preparing and maintaining regulatory intelligence and change management documentation.
- Contribute to regulatory compliance programs designed to minimize business disruption, regulatory risk, and potential delays to product commercialization and distribution.
- Stay informed about emerging regulatory trends and proactively identify requirements that could influence future products, technologies, or business processes.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related discipline; a Master's degree is preferred.
- 5+ years of professional experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or a related function 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.
- Proven experience conducting regulatory assessments and translating regulatory requirements into actionable recommendations for business and technical stakeholders.
- Experience managing or supporting compliance-related projects in cross-functional environments.
- Strong analytical and critical-thinking capabilities, with the ability to interpret complex regulatory information and identify business implications.
- Strong written and verbal communication skills, including the ability to prepare clear reports and presentations for management.
- Solid project management and organizational skills, with the ability to coordinate multiple regulatory activities and deadlines.
- Experience using regulatory intelligence platforms, compliance databases, dashboards, or other digital tools.
- Previous exposure to AI/software regulations, cybersecurity requirements, or chemical and environmental compliance frameworks is a plus.
- Experience supporting audits, inspections, regulatory authorities, or notified-body interactions is advantageous.
- Experience using AI or automation tools to improve regulatory intelligence workflows and knowledge management is an additional advantage.
Benefits:
- Comprehensive health care and employee benefit programs designed to support well-being both inside and outside work.
- Paid time off and other programs supporting work-life balance.
- Opportunities for professional development, continuous learning, and career growth within a global life sciences environment.
- Exposure to global regulatory programs and cross-functional initiatives spanning medical devices, IVDs, software, AI, and environmental compliance.
- Opportunities to work with digital and AI-enabled tools to modernize regulatory intelligence and compliance processes.
- Flexible working arrangements may be available for eligible roles, subject to applicable requirements and team policies.
- Opportunity to contribute to work that supports innovation in life sciences, diagnostics, biotechnology, and human health.
- Collaborative environment focused on continuous improvement, innovation, inclusion, and meaningful global impact.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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