Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Abbott seeks a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to support EU regulatory submissions for vascular medical devices. The role combines clinical evidence evaluation, regulatory documentation authoring, and cross-functional project coordination for CE Mark applications under EU MDR and MDD frameworks.

Responsibilities

• Independently create and maintain Clinical Evaluation Plans, Reports, and Safety/Clinical Performance Summaries
• Identify, evaluate, and synthesize clinical evidence from investigations, literature, and post-market surveillance
• Develop project timelines using management tools and communicate risks with cross-functional teams
• Lead or participate in regulatory responses to Notified Body submission questions
• Provide strategic regulatory guidance to new product development and sustaining teams

Requirements

• Bachelor's degree in science, engineering, or medical field required
• Thorough knowledge of EU MDR 2017/745, MDD 93/42/EEC, and MEDDEV 2.7/1 Rev 4
• Project management experience with demonstrated ability to meet tight timelines
• Strong medical and surgical terminology expertise and written/verbal communication skills
• 5-7+ years in clinical research, regulatory affairs, or medical device quality systems
• 3-5+ years writing or leading Clinical Evaluation Reports and related regulatory documents
• Advanced degree (Master's, RN, PharmD, PhD, or MD) preferred