Adam K.

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Pittsburgh, Pennsylvania, United States

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Timeline
About me
Senior Manager, Clinical Compliance | Medical Device Regulation Expert
Education
- University of Pittsburgh School of Medicine
  2015 - 2021
  Doctor of Philosophy - PhD Microbiology and Immunology
  Dissertation defended on October 27th, 2021
- North Central College
  2011 - 2015
  Bachelor’s Degree Biochemistry
Experience
- North Central College
  Nov 2011 - Jun 2015
  Stand-in Lab Assistant for introductory cellular biology, molecular biology and genetics coursePreceptor for introductory cellular biology, molecular biology and genetics courseLab Assistant for Genetics course Conducting experiments on E. coli to look at protein aggregation in conjunction with L-isoaspartyl protein carboxyl methyltransferase (PCM).
  - Lab Assistant
    Mar 2013 - Jun 2015
  - Undergraduate Student Researcher
    Nov 2011 - Jun 2015
- Virginia Tech
  May 2014 - Aug 2014
  Undergraduate Researcher
  Virology research position through the National Science Foundation's REU program at Virginia Tech.
- University of Pittsburgh School of Medicine
  Jun 2015 - Oct 2021
  PHD Student
  PhD student in the lab of Dr. Cristian Apetrei in the Division of Infectious Diseases at the University of Pittsburgh.
- RQM+
  Jan 2022 - Mar 2023
  Consultant
  RQM+ is the world's leading medical device and diagnostics focused, regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations.
- Philips
  Mar 2023 - now
  Lead the clinical compliance team for the Philips Hospital Patient Monitoring business unit. Ensure compliance to EU regulations (EU MDR, EU MDD) for HPM portfolio with the focus on clinical evidence through clinical evaluation reports and post-market clinical follow-up reports. Draft CERs/PMCFRs and maintain clinical information for select hospital patient monitors and medical device software (MDSW) to conform to MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745.
  - Senior Manager, Clinical Compliance
    Jan 2024 - now
  - Senior Medical Writer
    Mar 2023 - Jan 2024
Licenses & Certifications
- Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019
  TÜV SÜD
  Jun 2025
- Clinical Investigations and Evaluation for Medical Devices
  Symmetric Training
  Apr 2024
  View certificate
Honors & Awards
- Awarded to Adam K.
  10th IAS Conference on HIV Science Scholarship Award IAS 2019 Jul 2019 Travel and registration scholarship awarded for an oral presentation at the 10th IAS Conference on HIV Science, Mexico City, Mexico.
- Awarded to Adam K.
  Pitt AIDS Research Training (PART) Fellowship University of Pittsburgh Graduate School of Public Health, Infectious Diseases and Microbiology Aug 2018 Awarded a fellowship from a NIH-funded T32 Training grant from August 2018 through August of 2020.
- Awarded to Adam K.
  Young Investigator Scholarship 35th Annual Symposium on Nonhuman Primate Models for AIDS Aug 2017 Scholarship for an oral presentation at the 3th Annual Symposium on Nonhuman Primate Models for AIDS in Madison, Wisconsin.
- Awarded to Adam K.
  Immunology of Infectious Diseases Fellowship University of Pittsburgh School of Medicine Sep 2016 Awarded a training fellowship under an NIH-funded T32 training grant from 2016-2018.