Senior Analyst, Medical Writing

A company is looking for a Senior Analyst, Medical Writing, Clinical & Regulatory Affairs.

Key Responsibilities

Plan, prepare, and finalize regulatory documents for global post-market surveillance, including clinical evaluation plans and reports

Conduct literature and clinical data reviews to support regulatory document preparation

Collaborate with cross-functional teams to ensure regulatory documents meet guidelines and company standards

Required Qualifications

Minimum of a Bachelor's degree (BS / BA); advanced degree preferred

At least 4 years of relevant scientific / med tech experience; clinical research experience preferred

At least 3 years of medical writing experience; cardiovascular disease experience preferred

Authoring experience with CERs, post-market surveillance plans, SSCPs, and PMCFs required

Strong knowledge of FDA and EU MDR regulations and post-market requirements