Christopher Swanson

Manager of Regulatory Affairs at Cercacor

Christopher Swanson has extensive experience in Regulatory Affairs, primarily in the medical devices and healthcare industry. Christopher has held various managerial positions in reputable companies, including Cercacor Laboratories, The HydraFacial Company, Kerr Corporation, and Advanced Sterilization Products (ASP).

At Cercacor Laboratories, Christopher served as the Manager of Regulatory Affairs, providing leadership and guidance for new product development in diabetes management devices and health & wellness software products. Christopher also conducted audits to ensure compliance with FDA and ISO 13485 requirements.

While working at The HydraFacial Company, Christopher rebuilt the Regulatory Affairs department and led successful submissions and approvals/clearances of cosmetic and medical devices with regulatory agencies such as the FDA. Christopher also oversaw international registrations, reviewed marketing materials, and supported new product releases worldwide.

During their tenure at Kerr Corporation, Christopher led the Regulatory Affairs department in obtaining approvals/clearances for their medical devices and disinfection products from regulatory agencies like the FDA, EPA, and international authorities. Christopher also reviewed marketing materials and labeling changes and initiated cross-departmental projects to ensure ongoing compliance with new regulations.

At Advanced Sterilization Products (ASP), Christopher held the role of Staff Product Steward and Regulatory Affairs Specialist II. Prior to this, they worked as an Associate at PRTM, a Senior Regulatory Affairs Specialist at Advanced Bionics, and a Technical Service Specialist at Boston Scientific.

Christopher's early experience includes managing the Head Protection Research Laboratory, where they coordinated and performed testing on helmets and headgear to meet government standards. Christopher also conducted investigations and replication testing as an expert witness for accident cases.

Overall, Christopher Swanson has consistently demonstrated their expertise and leadership in Regulatory Affairs, ensuring compliance, successful submissions, and approvals of medical devices and healthcare products.

Christopher Swanson earned their Bachelor's degree in Biomedical Engineering from Rensselaer Polytechnic Institute in 1997. Christopher then pursued a Master's degree in the same field from the University of Southern California, which they completed in 1999. Later, in 2009, Christopher attended UCLA Anderson School of Management, where they graduated with an MBA in Business Administration. In addition to their formal education, they obtained several certifications, including Six Sigma Green Belt (CSSGB) from Johnson & Johnson in March 2015, and RAC (US) from the Regulatory Affairs Professionals Society (RAPS) in November 2013. Furthermore, in December 2013, they completed the Regulatory Affairs Certification Program (RAC-US).

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Timeline

  • Manager of Regulatory Affairs

    May, 2020 - present