Regulatory Affairs Manager

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule

Other

Environmental Conditions

Office

Responsibilities

Job Description

The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.

• 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.