RAQA Specialist

Intuitive · Bangalore

Source and collection record

Last observed by our collector: 9 October 2026 at 12:42 am IST. This is not a manual review or a confirmation from the employer.

Employer requisition: JOB216697

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Collected role description

Primary Function of Position The Regulatory Affairs Specialist supports the department by converting/creating the Medical Device Technical Documentation according to the India Medical Device Rules, evaluating medical device changes, determining and executing registration strategy and ensuring compliance of marketing material according to internal processes Essential Job Duties Prepares and submits medical device technical documentation according to India Medical device rules requirements Assesses the regulatory impact on the development of new devices or the changes to existing products Coordinates registration strategy with sales/marketing stakeholders Prepares and submits Medical Device registration dossiers for assigned geographies and ensures accurate records Replies regulatory inquiries to key stakeholders (e.g. Customer Service, Contract/Tender, Sales) Performs regulatory review of marketing material (e.g. brochures, presentations) for compliance to assigned geographies regulations Additional activities Supports Quality Management system activities such as CAPA or internal & external audits as needed Supports process improvement and implementation of regulatory projects/tools Assists and supports other employees, teams and field personnel as necessary Other regulatory tasks and projects may be assigned as necessary #LI-Hybrid