Staff Regulatory Affairs

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Staff Regulatory Affairs in India.

This role offers a high-impact opportunity to shape and safeguard global regulatory compliance across life sciences and medical device products in a fast-evolving international environment. You will act as a key driver of regulatory intelligence, translating complex global requirements into actionable insights that guide business and product decisions. Working within a global quality and regulatory team, you will collaborate closely with cross-functional stakeholders to anticipate regulatory changes and mitigate compliance risks. The position combines strategic thinking with hands-on regulatory expertise, including gap assessments, compliance tracking, and risk mitigation planning. You will also leverage modern digital and AI-enabled tools to enhance regulatory monitoring and horizon scanning. This is a remote role suited for a proactive expert who thrives at the intersection of regulation, innovation, and healthcare impact.

In this role, you will lead regulatory intelligence and compliance-driven initiatives to ensure products and systems remain aligned with evolving global standards. You will play a central role in identifying regulatory changes, assessing their impact, and guiding cross-functional execution of compliance strategies.

• Monitor and analyze global regulatory frameworks across IVD, medical devices, software, and environmental/chemical regulations (FDA, EU IVDR, REACH, RoHS, ISO standards, etc.)
• Develop detailed regulatory impact assessments and translate changes into actionable business recommendations
• Support regulatory strategy by providing intelligence-driven insights and maintaining regulatory dashboards and tracking systems
• Prepare executive summaries, compliance reports, and regulatory briefings for internal stakeholders
• Conduct compliance gap analyses and risk assessments in collaboration with Quality and Legal teams
• Ensure alignment with internal SOPs and global regulatory requirements while supporting audit readiness and compliance programs

Requirements

The ideal candidate brings deep regulatory affairs expertise in the life sciences or medical device industry, with strong experience in regulatory intelligence and compliance systems. You are analytical, detail-oriented, and comfortable working in a global, fast-paced environment.

• Master’s degree in life sciences, engineering, or a related field; advanced degree preferred
• 10+ years of experience in regulatory affairs or regulatory intelligence within IVD or medical device industries
• Strong knowledge of global regulatory frameworks including FDA, EU IVDR, ISO 13485, ISO 20916, and related standards
• Experience managing regulatory compliance programs, audit readiness, and tracking systems
• Familiarity with regulatory intelligence tools, digital platforms, or AI-enabled monitoring systems
• Strong analytical, communication, and stakeholder management skills
• Experience with AI/software or chemical/environmental regulations is a strong advantage
• Exposure to regulatory agency interactions or notified bodies is a plus

Benefits

• Fully remote working arrangement within India
• Competitive compensation aligned with global standards
• Comprehensive health and wellness benefits package
• Opportunity to work in a global life sciences and diagnostics environment
• Exposure to cutting-edge regulatory intelligence tools and AI-enabled systems
• Strong focus on learning, innovation, and continuous improvement culture
• Flexible working environment supporting work-life balance