James Smith

About James Smith

I help medical device companies move their products forward—compliantly, confidently, and with clarity. With a Ph.D. in Biomedical Engineering and over a decade in the medical device and diagnostic space, I specialize in transforming complex technical evidence into regulatory and quality documentation that drives decisions. Whether it\'s navigating FDA submissions, EU MDR compliance, or internal design controls, I bring both the strategic thinking and execution to get it done right. My experience spans regulatory strategy, quality systems, and technical writing—with a focus on Design History Files (DHFs), Technical Files, Clinical Evaluation Reports (CERs), Biological Evaluation Reports (BERs), biological risk assessments, and post-market surveillance deliverables. I’ve supported pre- and post-market efforts at every stage, and from every angle: from startups preparing for initial submissions to global manufacturers remediating legacy files, and even as a Notified Body reviewer assessing other companies\' compliance. I work cross-functionally with engineering, QA/RA, and external partners to align evidence with regulatory expectations and business goals. I don\'t just write documents—I craft persuasive, standards-driven narratives that withstand scrutiny and drive approvals. I bring: A deep working knowledge of ISO 13485, ISO 14971, ISO 10993, and EU MDR Firsthand experience with regulatory bodies, CRO coordination, and submission strategy A clear, strategic writing style that builds internal alignment and speeds external review The ability to spot gaps, recommend testing, and connect data to meaningful claims When you\'re facing a mountain of data, a tight deadline, or a vague regulatory requirement—I help connect the dots, shape the message, and deliver documents that move products forward. Who I support: Regulatory and quality teams managing documentation loads or audits R&D teams needing strategic writing input during design and development Startups getting regulatory-ready and risk-informed Global manufacturers remediating files for MDR, FDA, or internal alignment Notified Bodies and CROs seeking expert reviewers Let’s connect if you need a partner who can think like a regulator, write like a scientist, and move like a project manager.

Experience

1. Senior Research Scientist, Biocompatibility Specialist

   Zimmer Biomet

   Dec 2021 — Present

   As a senior biocompatibility consultant, I led comprehensive biological risk assessments for Class II and medical devices to ensure compliance with ISO 10993, EU MDR, and FDA requirements. My work spanned early-stage evaluations, legacy device remediation, and submission support for orthopedic implants, absorbable materials, and blood-contacting devices made from metals, plastics, and ceramics.I performed initial biocompatibility assessments on legacy products with minimal data, conducted gap analyses on partially characterized devices, and authored detailed Biological Evaluation Plans tailored to material composition, clinical use, and exposure profiles. When testing was required, I coordinated chemical characterization and biological endpoint testing with contract labs, ensuring alignment with ISO 10••••••18, and -5. I reviewed and approved test protocols, assessed results, and authored robust Biological Evaluation Reports that supported successful regulatory submissions.This work required close collaboration with cross-functional teams, including supplier quality, manufacturing, packaging, sterilization, clinical, and design teams. I gathered and synthesized evidence across departments to build comprehensive justification frameworks and align all documentation to regulatory expectations. I also partnered with toxicologists to support risk assessments and respond to regulator requests.I regularly supported FDA and Notified Body interactions by authoring responses to additional information requests. My strategic writing and risk-based justifications helped minimize delays and avoid unnecessary retesting, ultimately contributing to more efficient market access.Skills: Biocompatibility · ISO 10993 · EU MDR · FDA Submissions · Risk Assessment · Technical Writing · Chemical Characterization · Biological Evaluation Reports (BER) · Medical Devices · ISO 14971 · Toxicological Risk Assessment · Supplier Quality · Technical Documentation

Education

• University of Memphis

  Bachelor of Science (B.S.), Chemistry/Mathematical Sciences/Biology

  2003 — 2007

• University of Memphis

  Master of Science (M.S.), Biomedical/Medical Engineering

  2007 — 2009

• University of Memphis

  Doctor of Philosophy (Ph.D.), Biomedical/Medical Engineering

  2009 — 2014