Clinical Research Associate

Job Overview :

The position is responsible for providing regulatory and quality support pertaining to regulatory submission requirements for the client’s portfolio of medical device products. The position is responsible for providing reports required in regulatory submission for pre-approval and post approval of medical devices.

Responsibilities :

Prepare regulatory documents such as Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post market Surveillance (PMS) and Post Market Clinical Follow Up Plan (PMCF Plan) at different stages of the Design Review for new product approval and post approval of a product.

Assist in reviewing documents from regulatory and quality such as Summary of Safety and Clinical Performance (SSCP), Periodic Safety Updates Report (PSUR) and Risk Analysis Report.

Literature review for Post Market Clinical Follow Up Report and Clinical Evaluation Report

Support regulatory and quality for questions from notified bodies or local authority on PMS, IFU

Work with the project team leader to ensure the assigned tasks are done in a timely manner

Requirements :

Holds a degree in science, engineering, or medical fields. Scientific / research background required, with an understanding of research, regulatory or quality assurance.

Bachelor of Science or Master of Science with 1 to 3 years of related experience in clinical research or regulatory or quality assurance work.

General understanding of regulatory guidelines for CE, FDA

Highly proficient in spoken and written English.

Proficient in other spoken languages will be a plus point

Performed literature screening, analysis, appraisal, and weighting of data for relevancy and comprehensive analysis.