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Stacie Zaffke

Clinical Scientist | Medical Writer

I'm a medical device professional with 9+ years of experience in continuous improvement, quality assurance, and regulatory compliance. 

About Me.

I'm a clinical science medical device professional living in Minneapolis, MN. I'm a skilled communicator with a passion for standardization, process improvement, and software usability. 

I started working in the medical device industry in 2015 a quality assurance technical writer, and I've since supported publications as a clinical scientist and written clinical evaluation documentation as a post-market surveillance specialist. I've supported multiple therapies including vascular, structural heart, endsocopy, and neuromodulation.

I value quality and compliance. I believe in continuous learning, and I'm passionate about training new colleagues. 

In my free time, I enjoy hiking through Minnesota's beautiful state parks, playing board games, and writing short fiction.



Clinical Evaluation Scientist /

Post-Market Specialist

Boston Scientific

Peripheral Interventions | Endoscopy

  • Develops and maintains clinical evaluation reports (CERs) and post-market clinical follow-up reports.

  • Conducts thorough literature searches and compiles data from diverse sources.

  • Analyzes product benefit/risk profile and provides input to risk management deliverables.

  • Uses AI for data management and analysis for error-free clinical reporting while maintaining corporate privacy requirements.

  • Collaborates with cross-functional partners to develop clinical strategies and ensure alignment of clinical data with risk documentation.

  • Provides subject matter expert knowledge of clinical evaluation processes to core teams.

  • Develops and delivers training programs on document management, citation management, and literature review software to empower team members to be more productive and efficient.

  • Provides key information for the development of regulatory responses and submissions, including 510(k) submissions, Pre-market Approval (PMA) applications, and EU submissions complying with the European Medical Device Regulation (EU MDR).

  • Supervised intern, providing constructive feedback, hands-on learning, industry insights, and regular progress check-ins. Allocated project work according to the intern's abilities and interests.

  • Conducted the obsolescence process and executed post-market surveillance closeout activities for end-of-life products.


Labeling Technical Writer
Medtronic (contract)


  • Reviewed and approved changes to engineering documentation.

  • Attended technical reviews as a labeling Subject Matter Expert (SME).

  • Led technical reviews of labeling deliverables.

  • Used standardized criteria and specifications to identify EU Medical Device Regulation (MDR) related updates.

  • Authored changes to labeling content, maintaining compliance with new internal and external requirements.

  • Identified and wrote updates to labeling content in compliance with EU MDR requirements.

  • Audited labeling redlines and final drafts to ensure traceability of content changes.

  • Led labeling technical reviews for neuromodulation medical devices, ensuring compliance with EU MDR regulatory requirements.

  • Developed and implemented technical review procedures and checklists.

  • Identified and assessed potential regulatory risks.

  • Reviewed labeling and manuals for accuracy.

  • Coordinated with Regulatory and Quality Engineering stakeholders to ensure compliance.

  • Served as an independent reviewer on a labeling technical review team.

  • Provided expert insights and recommendations to ensure the accuracy, completeness, and clarity of labeling and manuals.

  • Led the revision and creation of clinician and patient-facing manuals to ensure compliance with the new EU Medical Device Regulation (MDR).


Technical Writer

Boston Scientific

Peripheral Interventions

  • Supported regulatory submissions for new product development peripheral interventions, interventional oncology, and interventional cardiology medical devices.

  • Reviewed and revised ASTM Standard documentation to ensure compliance with industry standards.

  • Led and executed on-site audits of preclinical reserach facilities, assessing organizational processes, subject documentation, safety, and compliance with internal and external requirements.

  • Represented the organization as a front-room Subject Matter Expert during audits.

  • Conducted comprehensive internal audit of laboratories.

  • Presented key insights and findings during design review meetings.

  • Engaged in Kaizen events to enhance operational workflows and boost overall efficiency.

  • Created and authored regulatory test plans for bench testing.

  • Performed summative evaluations for users across various experience levels.

  • Led a team in conducting User Acceptance Testing and directed the development and testing of scripts for a specific workstream.

  • Formalized, authored, and proofread engineering deliverables.

  • Conducted audits of documentation methodologies and procedures to ensure conformance with FDA Quality System Regulations (QSR), compliance with EU Medical Device Regulation (MDR), and alignment with international standards such as ISO 13485.

  • Oversaw and managed the NCEP (Nonconforming Events and Prevention) process for a project.

  • Maintains Quality Management System and ensures full compliance with internal and external standards and regulations.

  • Served as a site Subject Matter Expert (SME) for the document management system.

  • Supervised a technical writer and managed the obsolescence process for canceled New Product Development (NPD) projects.

  • Facilitated the mitigation of FDA site inspection findings.

  • Completed training, achieved certification as an instructor, and conducted classroom sessions for a rationales writing course.

  • Reviewed design activities, risk management, and usability engineering documentation methodologies and procedures.

  • Trained new technical writers on regulations, standards, and the quality system.

  • Revitalized and maintained project timelines and tracked process statuses using IBM M&A Accelerator for a multi-site acquisition. project.


Law Books

Regulatory Compliance

I specialize in regulatory compliance for medical devices, ensuring adherence to ISO 13485, FDA QSR, and EU MDR. My expertise spans clinical evaluations, breakthrough designations, IDE submissions, 510k and PMA submissions, labeling, and audit processes, demonstrating a commitment to upholding industry standards and regulations throughout the product lifecycle.

Stack of Files

Clinical evaluation

I've developed literature search strategies, defined safety endpoints, and supported product approvals. My role involves analyzing product benefit/risk profiles, collaborating on clinical strategies, and offering subject matter expertise to core teams. Additionally, I've conducted obsolescence processes and led labeling technical reviews.

Man Hands On Keyboard


I have strong technical skills and an interest in software usability. I've supported user acceptance testing and conducted training on a variety of software programs.

Proficiencies include: 

  • Content management systems 

  • Product lifecycle management and document management systems 

  • Statistical analysis software 

  • Systematic review software 

  • Project management software

  • Language models

Get in Touch

To contact me, please send me a message on LinkedIn

  • LinkedIn
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