Ken Pilgrim has over 20 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, 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 Files (MD / IVD); Risk Management files; and global regulatory strategy. Ken’s quality system background includes: implementing 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.