Senior Associate - Quality Assurance & Regulatory Affairs - Medical Devices

Location : Bangalore, Karnataka

Experience Level : Mid-Senior level

• Ensure SaMD product conformity in accordance with Wysa's QMS before release.
• Create and maintain technical documentation and declarations of conformity.
• Oversee and maintain post-market surveillance and vigilance reporting.
• Serve as the primary liaison with regulatory bodies on submissions, feedback, and incident notifications.
• Manage device labeling, advertising claims, and technical content for compliance.
• Drive regulatory strategy across EU MDR, UK MDR, and US FDA frameworks.
• Maintain compliance with international standards and their applicability.
• Own the effectiveness of internal and external quality processes.
• Lead clinical evaluation and post-market surveillance activities.
• Support SDLC process compliance in collaboration with product and tech teams.
• Implement and manage QMS, including audits (internal / external), CAPA processes, and non-conformances.
• Conduct company-wide training on regulatory procedures and track compliance coverage.
• Coordinate with external medical devices and allied consultants, notified bodies, and global teams.
• Establish dashboards and reporting metrics for senior management.

Qualifications & Skills :

(ref : iimjobs.com)