Medical Devices Quality and Regulatory Specialist

Specialist - MS&T (Medical Devices)

Job Description Summary

Location – Hyderabad #LI Hybrid
About the Role:
The purpose of the role is to be responsible for managing medical device service aspects focused to ensure accurate and timely preparation and maintenance of medical device technical documents, in accordance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements, the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures and agreed between MS&T NOCC and business partners within Operations network.

Job Description

Key Responsibilities:

• Technical documentation management (DHF, DMR, PMS)

• Risk assessment and gap analysis

• Technology transfer support

• Data analysis & visualization (Power BI)

• Data Integrity (DI) & Data Administrator (DA) checks

• Change Control management

• SaMD documentation & coordination with third-party manufacturers

• Creation/review of GxP documents (SOPs, reports, investigations)

• Audit support (internal & external)

• CAPA support and process improvement activities

• Compliance with ISO, FDA, MDR, and Novartis quality standards

Essential Requirements

• High quality output / accuracy / Right First Time

• Timely delivery of tasks

• Ability to manage deviations and escalate when needed

Desirable Requirements

• Experience with SaMD documentation

• Coordination with third‑party manufacturers

• Exposure to global operations

• Additional quality or regulatory certifications (implied)

Education

• Degree in Pharmacy, Science, Engineering, MBA, or equivalent from a reputed institute

Experience

• Minimum 6 years in MS&T, medical devices, Quality Assurance, Regulatory, or pharmaceutical manufacturing

• Strong GxP and cGMP knowledge

• Broad IT knowledge; proficient in MS Office

• Experience working with global stakeholders

• Excellent communication, presentation & analytical skills

• Project management experience

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Skills Desired

Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Control, Regulatory Compliance, Resilience and Risk Management