Regulatory Affairs Specialist

Role Overview:

NeuroEquilibrium is looking for Regulatory Affairs Specialist responsible for regulatory submissions, product registrations, license renewals, and compliance for medical devices in India and other countries. Supports Quality Management System (QMS), audits, CAPA, supplier/distributor quality, and ensures compliant labeling, documentation, and distribution practices in line with medical device regulatory requirements.

What is the role like:

For this role, we are looking for the people who has exposure in the global compliance requirements and documentation into healthcare and medical devices segments. Additional responsibilities, this role will have as below:

• Ensure regulatory compliance with relevant global medical device regulations.
• Prepare and manage regulatory submissions for medical device approvals, renewals, and change notifications.
• Monitor and interpret CDSCO, MDR, FDA, TGA, SFDA and other device-related regulations.
• Maintain licenses, certifications, and regulatory documentation.
• Support QMS implementation, internal/external audits, validation and CAPA processes.
• Review and approve medical device labels, artworks, and promotional content.
• Manage supplier/distributor quality and device complaint handling.
• Coordinate with consultants, government agencies, and internal teams.
• Evaluate and approve design documentation, verification and validation protocols, and reports to ensure regulatory compliance.
• Conduct risk assessments as per ISO 14971 and maintain risk management files throughout the product lifecycle.
• Ensure smooth design transfer and post-market activities, driving continuous compliance and improvement.
• Prepare technical documents to support country- specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including submissions in USA (510k), Europe and other ROW Countries.

Skills do we look for:

• Strong interpersonal skills.
• An excellent communicator and goal oriented.
• A good researcher about the latest trends in the regulatory and compliances fields.
• Experience in regulatory compliance of neurological diagnostic devices is preferred

How to Apply:

Please share your details along with the profile with us at hr1@neuroequilibrium.in