Luke Baker
EU MDR and CER Specialist - Project Management, Writing, & Consulting
- Role
- Senior Consultant at Writeline Consulting, Inc
- Location
- Louisville, KY, US
- LinkedIn followers
- 500 followers
About Luke Baker
I have 7.5 years of experience authoring biomedical documentation including Clinical Evaluation Plans (CEPs) and Reports (CERs), Post-market Clinical Follow-up (PMCF) Plans and Reports, and Summary of Safety and Clinical Performance (SSCP) documents. I manage multiple concurrent MDR and Rev-4 compliant CER projects for peripheral intervention, cardiovascular, and neuromodulation class IIa and class devices. I excel at collaborating with project stakeholders from across multiple business units to ensure that documents are delivered on time and ready for submission. My PhD work in Molecular, Cellular, and Developmental Biology prepared me to write clearly and concisely on complex biomedical and scientific subjects. I am an expert in the literature review process and I love writing a state-of-the-art literature review.
Experience
Senior Consultant
Jan 2026 — Present
Education
Indiana University Bloomington
Doctor of Philosophy (PhD), Developmental Biology
2011 — 2018
Transylvania University
Bachelor of Arts (BA), Biology, General
2007 — 2011
Skills
- Genetics
- Teaching
- Research
- Polymerase Chain Reaction (Pcr)
- Student Recruiting
- Transcription
- Community Outreach
- Public Speaking
- Powerpoint
- Microsoft Excel
- Communication
- Western Blotting
- Organization
- Social Media
- Education
- Molecular Genetics
- Microsoft Powerpoint
- Laboratory
- Developmental Biology
- Dissection
- Microsoft Office
- Friendly Personality
- Event Planning
- Scientific Writing
- Data Analysis
- Leadership
- Graduate Recruitment
- Laboratory Skills
- Pcr
- Critical Thinking
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