1 Opening(s)
3.0 Year(s) To 5.0 Year(s)
5.00 LPA TO 7.00 LPA
Regulatory Affairs Executive – Medical DevicesExperienced Regulatory Affairs Executive with strong expertise in Medical Writing, EU MDR 2017/745 compliance, and regulatory documentation for Class IIb & Class III Implantable Intra Ocular Lens (IOL) devices. Skilled in handling Clinical Evaluation documentation, Technical Files, Risk Management, Post-Market Surveillance, and QMS documentation in ...
2 Opening(s)
3.0 Year(s) To 4.0 Year(s)
6.50 LPA TO 8.00 LPA
Role:
• Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.
• Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.
• Drafting and revising pre-clinical summaries.
• ...