14/04 Bhavana Jain
Talent Partner at Talent Xo

Views:176 Applications:6 Rec. Actions:Recruiter Actions:1

Medical Writer - Regulatory Affairs - Clinical Evaluation Reports (2-5 yrs)

Bangalore/Gurgaon/Gurugram/Mumbai Job Code: 21584

Role & Responsibilities

- Author sections of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical

- Follow-up (PMCF) reports in compliance with EU MDR 2017/745.Support in PMS activities

- Support in preparing dossier for FDA 510k submissions, including designing clinical validation studies

- Independently monitors activities to compile, update, and maintain regulatory records

- Coordinate with stakeholders from various departments across the company

Ideal Candidate :

- Having a keen interest in healthcare

- Able to work independently and as part of a team in getting things done

- Having 2-3 years of experience in a scientific/medical writing role in the medical device industry

- Able to work in a fast paced environment

- Having knowledge of biostatistics

- Current advancements in the field of AI in Healthcare

- Strong CER Writer Profile

- Must Have 2+ years of experience in a scientific / medical writing role in the Medical device / Pharmaceutical industry

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