Manager, Medical Writing

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

Key Responsibilities

Plan, prepare, and finalize regulatory documents focused on global post-market surveillance requirements

Support the establishment and execution of document timelines and strategies to maintain compliance with EU regulatory requirements

Conduct literature and clinical data reviews to support regulatory document preparation and submissions

Required Qualifications

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

At least 5 years of relevant scientific / med tech experience required

At least 4 years of relevant medical writing experience required

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

Authoring experience with clinical evaluation reports and post-market surveillance plans strongly preferred