Job Description

Req ID: 391784

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Compliance & Regulatory Consultant to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Compliance & Regulatory Consultant

Company: NTT DATA
Location: Bangalore / Hyderabad (Hybrid/Remote)
Experience: 3-6 Years
Open Positions: 2-3

Job Summary

NTT DATA is seeking a Compliance & Regulatory Consultant with hands-on experience in EU MDR (2017/745) and/or IVDR (2017/746) to support regulatory compliance, CE Marking activities, product registrations, technical documentation, and lifecycle management of Medical Device and IVD products.

Key Responsibilities

• Prepare, review, and maintain Technical Documentation and regulatory submissions.
• Support CE Marking activities and coordinate with Notified Bodies.
• Perform regulatory impact assessments for product, manufacturing, labeling, and process changes.
• Manage product registrations, renewals, and compliance activities.
• Contribute to Post-Market Surveillance (PMS) and vigilance activities.
• Collaborate with Quality, R&D, Clinical, Manufacturing, and Product Management teams.
• Ensure compliance with EU MDR, IVDR, and applicable quality standards throughout the product lifecycle.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy, or related discipline.
• 3-6 years of Regulatory Affairs experience within Medical Devices and/or IVDs.
• Strong knowledge of EU MDR, IVDR, and CE Marking requirements.
• Experience with technical documentation, regulatory submissions, and change impact assessments.
• Understanding of medical device lifecycle management, risk management, and post-market surveillance.
• Excellent communication, documentation, and stakeholder management skills.

Preferred Qualifications

• Experience supporting Class II/III Medical Devices and/or IVD products.
• Exposure to global regulatory frameworks such as FDA and Health Canada.
• RAC certification and familiarity with ISO 13485 and ISO 14971.

Key Skills

EU MDR, EU IVDR, CE Marking, Regulatory Submissions, Technical Documentation, Product Registration, Change Control Assessment, Notified Body Coordination, Post-Market Surveillance, Vigilance, Risk Management, Medical Devices, IVD Regulations, Regulatory Compliance, Lifecycle Management.

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.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, 

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