Product Registration Specialist (Global Regulatory Affairs - IVD & Medical Devices)

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We are currently seeking a Product Registration Specialist (Global Regulatory Affairs - IVD & Medical Devices) to join our team in Bangalore, Karntaka (IN-KA), India (IN).

Job Title: Product Registration Specialist (Global Regulatory Affairs - IVD & Medical Devices)

Location: Bangalore (WF), Hybrid 2-3 days in a week

Notice period: 30 Days

Role Summary

The Product Registration Specialist is responsible for leading complex global regulatory submissions for In Vitro Diagnostics (IVD) and Medical Device portfolios. This role drives strategic regulatory planning, ensures compliance with international regulatory frameworks, and enables successful market access across global regions. The position requires strong technical expertise, hands-on submission experience, and the ability to collaborate cross-functionally while mentoring junior regulatory professionals.

Key Responsibilities

Regulatory Strategy & Submission Management

• Develop and execute comprehensive global regulatory strategies for new product registrations, renewals, and change controls across major international markets.
• Lead preparation, review, and submission of regulatory dossiers under EU MDR, IVDR, FDA (510(k), PMA), and other regional regulatory frameworks (APAC, LATAM, EMEA, etc.).
• Manage the end-to-end regulatory submission lifecycle including gap analysis, remediation planning, dossier compilation, submission tracking, and response coordination.
• Coordinate and manage multiple concurrent submissions across diverse geographies.

Regulatory Compliance & Authority Interaction

• Serve as primary liaison with Notified Bodies and global health authorities to address queries, deficiencies, and approval requirements.
• Ensure compliance with applicable international regulations and standards.
• Support post-market regulatory compliance activities, including change assessments, labeling reviews, and vigilance documentation.

Cross-Functional Collaboration

• Partner closely with R&D, Quality, Clinical, and Manufacturing teams to provide regulatory input during product design and development phases.
• Ensure regulatory requirements are integrated into technical documentation and design history files.
• Provide guidance to regional regulatory teams regarding submission requirements, formats, and timelines.

Documentation & Process Excellence

• Maintain accurate and up-to-date regulatory documentation, databases, and submission records.
• Ensure proper documentation practices in alignment with global regulatory standards and internal quality systems.
• Identify and implement process improvement initiatives within submission preparation and document management workflows.
• Mentor and review work of junior regulatory specialists to ensure high-quality deliverables.

Qualifications & Experience

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field (Master's degree preferred).
• Minimum 12 years of experience in global Regulatory Affairs within IVD and/or Medical Device industries.
• 5+ years of demonstrated expertise in EU MDR, IVDR, FDA 510(k)/PMA pathways, and other international product registration frameworks.
• 5+ years of proven track record of successful hands-on submission execution and direct communication with regulatory authorities.
• 5+ years of experience managing simultaneous regulatory submissions across multiple global markets.
• Strong technical writing, analytical thinking, and cross-functional collaboration skills.
• Proficiency with digital submission platforms, eCTD systems, and document control systems.
• Ability to balance strategic regulatory planning with operational execution.

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer,we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

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