Our Client, a world leader in Healthcare/Medical Devices MNC in Bangalore seeks senior professionals for Quality & Regulatory role.

Looking for candidates with :

Experience : 14 - 22 yrs

- Drive the Q&R Strategy across Product organization and ensure the products are designed as per the required regulatory standards

Design Control Owner for the product :

- Part of Core Team as Q&R representative, Approves the product release by being part of Project/Management Milestone review.

- Provide advice and counsel to staff regarding compliance with FDA, MDD as well as global regulatory standards to ensure that design team factors it in their development and ensure the Compliance to the established procedures.

- Participate in the review of process/product changes, labelling, complaints, etc., to determine the need for regulatory submissions and to ensure compliance to FDA and international requirements for design control.

- Own Quality Plan, compliance reports, milestone checklists, Participate in Milestone reviews, Safety Defect Classification, Design Reviews.

- Support on the Risk management activities and essential requirements analysis including standards review and evidence of conformity.

- Accountability for Process Compliance across the Program for all functions.

- Establish links with the BIU Q&R organization via the BIU Q&R Agreement.

Usha M P

M : 9845530896

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