Quality and Regulatory Analyst Job in Bangalore at Beckman Coulter

Beckman Coulter Diagnostics is hiring for the role of Quality and Regulatory Analyst!

Responsibilities of the Candidate:

• Make a literature search plan and document the references as per CPR (Clinical performance report).
• Writing scientific validity report (SVR)/state-of-the-art (SOTA)/clinical approaches for a device following global SOP.
• Maintain knowledge of current related internal and external standards, regulations, and technologies (for example Flow cytometry).
• Search in regulatory database (as example MAUDE) for Post-market Clinical Surveillance data for In-vitro diagnostic devices and medical devices.
• Make search strategies according to customer needs: PubMed, M-library, and Cochrane databases using the PICO method assess the articles based on inclusion and exclusion criteria and summarize the results in respective reports.
• Make a post-market surveillance plan and summarize the PMS findings in a PMS Report/PSUR in-vitro diagnostic devices With clear and factual communication, you will follow up on files, organize the necessary reviews with the various stakeholders (Engineering, R&D, Manufacturing, Quality Control, Marketing).

Requirements:

• Communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators
• Ability to drive results, foster teamwork, handle pressure, and provide feedback
• Must be able to demonstrate skills in root cause investigation and problem-solving
• Must have critical thinking skills and good judgment working in an independent environment
• Organized and detail-oriented
• High level of initiative, self-motivation, and energy
• Reliable and responsive
• Customer focused
• High level of integrity
• Goal-oriented, interpersonal, self-motivated, and team player