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:

- Minimum bachelor's qualification in any of engineering, science, law, medicine, pharmacy.

- 4 to 6 years of professional experience in regulatory affairs and in QMS of SaMD/AiaMD.

- At least managed one end-to-end QMS to medical device certification of an SaMD device.

- Experience with standards- ISO 13485, IEC 82304/62304, ISO 14971, Usability engineering, 21 CFR 820.

- Ability to learn quickly, work independently, and maintain professional skepticism.

- Ability to work in a fast paced or rapidly changing environment.

- Highly organized and detailed-oriented.

- Excellent collaborator and communicator.

- Excellent analytical and writing skills.

- Proficiency in MS Office and Google workspace.