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Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

Ken Pilgrim

Program Manager - RA/QA
Emergo by UL, Canada

Ken Pilgrim has over 25 years of industry experience at the Manager / Director level, overseeing corporate quality systems and providing input on business decisions and strategy, regulatory oversight, and risk management strategies for existing and new products. Ken specializes in regulatory submissions, including those for IVDs, software (SaMD), implantable devices, and tissue products. His expertise includes international regulatory compliance such as MDR/IVDR support and strategy; 510(k) clearances and other FDA activities such as Pre-Sub meetings and 513(g)s; Class II – IV Medical Device Licenses for Health Canada; EU Technical Documentation (MD / IVD); Risk Management files; and global regulatory strategy. Ken’s quality system background includes: implementing and auditing quality management systems (QMS) and supplier audits to FDA QSR, J-GMP, ISO 13485, and MDSAP. Additionally, Ken oversees EMERGO by UL’s RA/QA Consulting activity in Canada. In this role, he has peer reviewed 100+ regulatory filings and reports.

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