Senior
Regulatory Affairs Specialist

Role
Summary

The Senior
Regulatory Affairs Specialist will support the development and execution of
global regulatory strategies for medical devices and combination products. This
role is responsible for preparing regulatory submissions, maintaining product
registrations, supporting product lifecycle activities, and ensuring compliance
with applicable global regulatory requirements. The position requires close
collaboration with cross-functional teams including R&D;, Quality Assurance,
Clinical Affairs, Manufacturing, Supply Chain, and Marketing.

Key
Responsibilities
- Support the development and
implementation of regulatory strategies for medical devices and
combination products across global markets.
- Prepare, compile, review, and
maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR
Technical Documentation, and international registration dossiers.
- Perform regulatory impact
assessments for product design changes, manufacturing changes, software
updates, supplier changes, process changes, and labeling revisions.




- Support product lifecycle
management activities by maintaining regulatory compliance and global
market registrations.
- Prepare and maintain Technical
Documentation, GSPR checklists, compliance matrices, and regulatory
evidence packages.
- Review and update product
labeling, Instructions for Use (IFUs), packaging artwork, UDI
requirements, and marketing materials to ensure regulatory compliance.
- Support regulatory activities
during product development, design reviews, risk management, verification
and validation activities, and change control processes.
- Support regulatory strategy and
documentation activities for combination products.
- Prepare documentation packages
for internal audits, supplier audits, notified body audits, and regulatory
inspections.
- Maintain regulatory databases,
submission trackers, product registration records, and compliance
documentation systems.
- Conduct regula

📌 Senior Regulatory Affairs (Bengaluru)
🏢 Healthminds Consulting
📍 Bengaluru