Experience

Natural Cycles°

• Sweden
• Wellness and Fitness Services
• 1 - 100 Employee

• Senior Regulatory and Compliance Manager

  • Dec 2022 - Present

• Regulatory and Compliance Manager

  • Aug 2021 - Dec 2022


Ithemba, LLC
• United States
• Biotechnology
• Co-Founder

  • Dec 2015 - Present


Stryker

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Specialist

  • Mar 2020 - Aug 2021

• Regulatory Affairs Specialist

  • Jan 2020 - Mar 2020

• Regulatory Affairs Associate

  • Jul 2018 - Jan 2020



Johns Hopkins Technology Ventures (JHTV)

• United States
• Research Services
• 1 - 100 Employee

• Commercialization Academy Intern

  • Oct 2016 - Apr 2018

  Evaluate Johns Hopkins University and Hospital invention disclosures Investigate literature and patents relevant to the proposed invention and use this information to determine market size and key market factors Generate a potential value proposition and synthesize a recommendation for the inventor Evaluate Johns Hopkins University and Hospital invention disclosures Investigate literature and patents relevant to the proposed invention and use this information to determine market size and key market factors Generate a potential value proposition and synthesize a recommendation for the inventor

• Regulatory Affairs Intern

  • May 2017 - Aug 2017

  Generated streamlined 510(k) folder structure and submission template to make departmental 510(k) submissions more organized, standardized, and straightforward Collaborated with the Engineering Operations department to create a database linking 510(k) reports with test lab reports and R&D project numbers Worked on two comprehensive Excel-based projects to improve departmental visibility over all Stryker Spine CE marked products and OEM products Learned about the new product development process and business integration by parsing 1,600+ page DHF from recent Stryker acquisition Show less



Johns Hopkins Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Student Research Assistant

  • Jan 2016 - Feb 2017

  Conduct materials science and engineering research in laboratory of Dr. Mao at the Johns Hopkins Hospital Work with post-doctoral researcher to optimize therapeutic potential of human neural stem cells to promote brain tissue regeneration after traumatic brain injury using spheroids made of hydrogel and nanofibers Conduct materials science and engineering research in laboratory of Dr. Mao at the Johns Hopkins Hospital Work with post-doctoral researcher to optimize therapeutic potential of human neural stem cells to promote brain tissue regeneration after traumatic brain injury using spheroids made of hydrogel and nanofibers



Johns Hopkins University

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• PILOT Leader

  • Aug 2015 - Dec 2016

  Lead weekly Calculus 1 tutoring sessions with groups of 8-12 students Facilitate team learning and help freshman with their college transition Lead weekly Calculus 1 tutoring sessions with groups of 8-12 students Facilitate team learning and help freshman with their college transition



Cleveland Clinic

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Innovations Intern

  • May 2016 - Jul 2016

  Researched invention ideas from the Cleveland Clinic Neurological Institute and evaluated their commercial potential Conducted prior art searched and market research to determine viability and feasibility of moving invention ideas through the medical device development process Learned about medical device regulations and helped create a FDA pre-submission package to accelerate the approval pathway for a promising invention Researched invention ideas from the Cleveland Clinic Neurological Institute and evaluated their commercial potential Conducted prior art searched and market research to determine viability and feasibility of moving invention ideas through the medical device development process Learned about medical device regulations and helped create a FDA pre-submission package to accelerate the approval pathway for a promising invention



Case Western Reserve University

• United States
• Higher Education
• 700 & Above Employee

• Student Research Assistant

  • Nov 2011 - May 2014

  Studied the inflammatory response that is formed when microelectrodes are implanted directly into the brain to facilitate brain-computer interfaces and help traumatic brain injury patients Researched focused on materials and drug delivery mechanisms to decrease inflammatory response Co-authored a paper published in Biomaterials Selected to attended and present research poster at I-SWEEEP international science competition in Houston, Texas in May 2014 Studied the inflammatory response that is formed when microelectrodes are implanted directly into the brain to facilitate brain-computer interfaces and help traumatic brain injury patients Researched focused on materials and drug delivery mechanisms to decrease inflammatory response Co-authored a paper published in Biomaterials Selected to attended and present research poster at I-SWEEEP international science competition in Houston, Texas in May 2014