Regulatory Affairs Manager

• Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
• Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
• Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
• Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
• Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
• Lead local performance evaluations, tests, and clinical studies to support product registration in India.
• Participate in Animal Health regulatory submissions and support the distributed team as needed.
• Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
• Review advertisement materials for compliance with MD/IVD regulations in South Asia.
• Analyze new and existing regulations, preparing impact assessments for LSG projects.
• Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
• Participate in regulatory/quality audits, exhibitions, and conferences.
• Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
• Perform other tasks as assigned by the line manager.

• Bachelor’s degree or higher in Engineering, Sciences, or Medicine.
• Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.

• Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
• Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
• Strong planning and organizational skills for regulatory submissions and project management.
• Excellent communication skills, including written, verbal, and presentation abilities.
• Strong project management skills with the ability to lead regulatory projects.
• Strong analytical skills, proactive, and a resourceful problem solver.
• Ability to work effectively under pressure and manage flexible working hours.
• Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
• Experience in leading compliance activities, including post-market surveillance and advertisement review.
• Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
• Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.

Thermo Fisher Scientific