Apply for the Regulatory Affairs Manager Job at Thermo Fisher Scientific for IVD and medical devices.
Organization: Thermo Fisher Scientific
Position: Regulatory Affairs Manager
Location: Bangalore, Karnataka, India
Job Type: Full-Time | Fully Onsite
Job ID: R-01321070
Department: Quality & Regulatory
Work Schedule: Other | Office Environment
About Thermo Fisher Scientific
At Thermo Fisher Scientific, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. Our Quality and Regulatory teams play a vital role in ensuring that our products and services meet the highest standards of accuracy, safety, and effectiveness. We take pride in doing things right the first time and with the right intentions — always keeping our customers and global healthcare in focus. Regulatory Affairs Manager Job at Thermo Fisher Scientific
As part of our global team, you’ll work on meaningful projects, gain exposure to international markets, and develop your expertise in a collaborative, growth-oriented environment. Regulatory Affairs Manager Job at Thermo Fisher Scientific
Position Overview
The Regulatory Affairs Manager will oversee premarket approvals and post-market vigilance activities for In-Vitro Diagnostic (IVD) and Medical Devices within the Life Sciences Group (LSG) across the South Asia (SA) region. This role demands strong regulatory expertise, leadership, and strategic insight to support compliance, quality systems, and market access initiatives in India and beyond. Regulatory Affairs Manager Job at Thermo Fisher Scientific
You will collaborate with cross-functional teams — including R&D, QA, Operations, and Product Management — to ensure regulatory compliance throughout the product lifecycle.
Key Responsibilities
- Regulatory Submissions: Manage and execute regulatory submissions for LSG IVD and Medical Devices in South Asia, ensuring adherence to regional regulations and internal timelines.
- Compliance Implementation: Support regulatory processes at the LSG India plant, maintaining alignment with Quality Management System (QMS) and Good Manufacturing Practice (GMP) requirements.
- Cross-Functional Collaboration: Work with R&D, Operations, Quality Assurance, and Product Managers to ensure all products comply with applicable regulatory standards.
- Regulatory Strategy: Conduct investigations, perform regulatory analyses, define strategies, and communicate progress to project stakeholders and management.
- Documentation Management: Prepare, review, and maintain technical files and regulatory dossiers to support product registration and global submissions.
- Clinical Studies & Evaluations: Oversee local performance evaluations, testing, and clinical studies for product registration in India.
- Post-Market Vigilance: Lead post-market surveillance activities, resolve technical complaints, and ensure corrective and preventive actions are implemented effectively.
- Advertisement Review: Evaluate marketing and promotional materials for compliance with Medical Device (MD) and In-Vitro Diagnostic (IVD) regulations across South Asia.
- Regulatory Intelligence: Monitor and interpret new or changing regulations, assessing their impact on ongoing and future LSG projects.
- Stakeholder Engagement: Establish and maintain strong networks with consultants, policymakers, and regulatory authorities, including Indian CDSCO (Central Drugs Standard Control Organization).
- Audit & Representation: Participate in regulatory audits, quality inspections, industry exhibitions, and professional conferences.
- Cross-Regional Collaboration: Provide regulatory and scientific support to the Global and APAC LSG Regulatory Affairs teams.
- Regulatory Affairs Manager Job at Thermo Fisher Scientific
Education and Qualifications
- Bachelor’s degree or higher in Engineering, Sciences, or Medicine (advanced qualifications preferred).
- Minimum 10 years of experience in regulatory affairs for Medical Devices and/or In-Vitro Diagnostic Devices, with strong experience in Indian CDSCO regulations.
Essential Skills and Abilities
- In-depth knowledge of South Asian and Indian CDSCO regulations, standards, and guidance for Medical Devices and IVDs.
- Strong understanding of regulatory frameworks, product registration, and strategic compliance analysis.
- Excellent project management and planning capabilities for regulatory submissions and lifecycle management.
- Outstanding written, verbal, and presentation communication skills.
- Proven ability to lead regulatory projects and manage complex timelines.
- Strong analytical mindset with proactive and problem-solving approach.
- Capable of managing multiple priorities under pressure while adapting to changing regulatory landscapes.
- Experienced in post-market surveillance, advertisement review, and regulatory risk assessment.
- Skilled at building professional networks with consultants and government regulatory authorities.
- Effective in cross-functional teamwork to ensure timely and compliant product approvals.
- Regulatory Affairs Manager Job at Thermo Fisher Scientific
Why Join Thermo Fisher Scientific
At Thermo Fisher Scientific, you’ll be part of a global organization that values innovation, collaboration, and continuous improvement. We provide opportunities to grow within a company that plays an essential role in advancing science and healthcare. Regulatory Affairs Manager Job at Thermo Fisher Scientific
By joining our Quality & Regulatory team, you’ll contribute to ensuring that our products meet the highest global standards and help bring life-changing technologies to market responsibly and efficiently. Regulatory Affairs Manager Job at Thermo Fisher Scientific
How to Apply
Interested candidates can apply directly through the Thermo Fisher Scientific Careers Portal.
Join Thermo Fisher Scientific and make an impact by leading regulatory excellence in the life sciences and medical device industry.
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