Senior Medical Writer / Senior Project Manager, Clinical Evaluation
Abbott · Santa Clara, CA +1 more
Medical AffairsFull-time$90k–$180kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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