Talent Partner at Talent Xo
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Medical Writer - Regulatory Affairs - Clinical Evaluation Reports (2-5 yrs)
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
