Ken Campanale

Consultant, Quality and Regulatory Systems

Ken is a senior executive and educator with experience in global Regulatory Affairs, Clinical Research, Quality Systems, and R&D in the Medical Devices industry. His key accomplishments include implementing new product development processes and design controls within global regulatory requirements and ensuring timely product clearances with FDA and regulatory bodies worldwide.

Ken has served as an Adjunct Instructor of Operations Management and Project Management for the Endicott College School of Professional Studies. For 5 years he was also an Instructor in the Northeastern University Masters of Science Regulatory Affairs Program, where he taught Food, Drug, and Medical Device Regulatory Law, Introduction to Drug and Medical Device Regulations, New Drug Development; Medical Device Development, and a QA/RA Overview.

Ken is a Lead Medical Assessor working for a number of ISO Registration Bodies. Ken has been trained to conduct FDA QSIT audits as part of the FDA Third Party Reviewer Program and ISO 13485 Registration audits. Ken is also a Lean Six Sigma Certified Instructor.

Ken’s industry affiliations include the Regulatory Affairs Professionals Society (RAPS), ASQ, and MassMEDIC; SME.

Education
Master of Education (M.Ed.) from Worcester State University.
CQE from ASQ
RAPS certification
Lean Six Sigma Green Belt
Design of Experiment certification
ISO 13485:2016 In-House Internal Auditor
ISO 13485:2016 & FDA 21 CFR 820 Auditing to the Integrated Standard
ISO 13485:2016 Exemplar Global Lead Auditor
MDSAP & ISO 13485:2016 Exemplar Global Internal Training
FDA Third Party Reviewer Program
Lead Medical Assessor

 

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