Senior Medical Writing & Regulatory Lead

HCL Tech; Dubai; On-site; AED 180,000 - 300,000; Full time

Job summary

HCL Tech in Dubai is seeking a Senior Medical Writer to prepare Clinical Evaluation Plans, CERs and related regulatory documents for Medical Devices, ensuring alignment with MEDDEV Rev 4 and MDR requirements. The role involves literature review, data interpretation, and collaborative writing with cross-functional teams.

Ideal candidates hold a Life Sciences degree, possess strong medical writing skills, and understand EU MDR guidelines.

Qualifications

• Master's or Bachelor's in Life Sciences or related field.
• Basic understanding of human anatomy and physiology; knowledge of disease pathology helpful.
• Knowledge of MDCG MEDDEV 2.7/1 Rev 4 and EU MDR.

Responsibilities

• Creation and update of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Medical Devices per MEDDEV Rev 4 and MDR requirements.
• Experience with reports such as Subject Device and State of the Art Literature Reports, PMS Plan, PMSR, PSUR, PMCF Plan and SSCP.
• Develop protocols, clinical study reports and Investigator's brochure; create Clinical Evidence Summaries and risk-benefit analyses.
• Literature searches, summarization, and analysis of data from clinical studies; contribute to consulting, editing, and statistical reports.

Skills

Medical writing

Communication skills

Scientific knowledge

Education

Life sciences degree

Job description

HCL Tech in Dubai is seeking a Senior Medical Writer to prepare Clinical Evaluation Plans, CERs and related regulatory documents for Medical Devices, ensuring alignment with MEDDEV Rev 4 and MDR requirements. The role involves literature review, data interpretation, and collaborative writing with cross-functional teams.

Ideal candidates hold a Life Sciences degree, possess strong medical writing skills, and understand EU MDR guidelines.