Wipro - Senior Consultant - Regulatory Affairs - Medical Device Domain

Roles and Responsibilities :

- Serve as an executive connect with the customers and team.

- Drive GTM and be willing to travel and make a difference

- Engage Global Client technology teams.

- Provide Guidance and Review of Design Requirements based on applicable IEC Standards 60601-1 and 61010-1 and Particular standards of Medical Device Products

- Understand and support team in Deploying system requirements to subsystems such as hardware, mechanical, software, reliabilityetc..

- Support and provide Guidance to Delivery team for Performing Pre-compliance and Compliance Testing; Interaction with Notified body.

- Support Delivery team by providing inputs and have Strong Knowledge in Product Risk Management / Hazard Analysis Process based on ISO 14971.

- Documentation support for any Medical Device Certifications, 510(k) and TF for FDA and MDD requirements.

Desired/Preferred Qualifications :

- Prior work in the release of medical products in a regulated environment (Thorough knowledge of FDA regulations / Design Controls), Understanding of ISO 13485/IEC 62304/ISO 14971 and Part 820 QSR Requirements. Auditing Experience in medical Device Domain projects.

- Passionate about making innovations.

- 10+ years Technical leadership

- Experience with a successful track record in releasing products to market

- Knowledge and experience using DRM/DFSS/Six Sigma is a plus