Regulatory Affairs Specialist / Senior specialist – Medical Devices

Location : Bengaluru / Hybrid

Experience : 5 - 8 years

Overall Package : 8 - 10 LPA

Role Summary :

The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally with design, quality, clinical, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle and to maintain an effective Quality Management System (QMS) aligned with ISO 13485 and other applicable standards.

Key Responsibilities :

• Prepare, review, and submit regulatory dossiers and applications to  CDSCO , including :
• Manufacturing and import licenses, Test licenses, Device registration dossiers,     Post-approval variations and renewals
• Prepare  Technical Documentation  and  Design Dossiers  as per EU, India requirements.
• Prepare  US FDA submissions , including :
• 510(k) ,  PMA ,  De Novo , and  Q-Submission  documentation.
• Address queries, deficiencies, and audits of  Notified Bodies, CDSCO, and FDA reviewers
• Support implementation and maintenance of  ISO 13485 : 2016, 21 CFR Part 820 (QMSR), and MDSAP requirements.
• Assist in creation and control of SOPs, CAPA, internal audits, supplier audits, risk management, and document control.
• Participate in  management reviews  and  regulatory audits .
• Ensure QMS integration with regulatory submissions (Device Master Record, Design History File).

Qualifications & Required Skills :

Preferred / Desirable :