Chris Ozga

Senior Regulatory Affairs Associate


Administration, Loyola University

Research Scientist

General and Children’s Health

Regulatory Professional

Apicona Medical Center, Wellington, FL . Family Medicine

Non-Executive Director (Health)

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Chris is an experienced leader in medical devices and diagnostics, specialising in medical device commercialisation, Regulatory Affairs (TGA, FDA, EU-MDR, Medsafe, Health Canada, APAC), Quality Management Systems, certification and surveillance audits for ISO13485, CE and MDSAP.

He also possesses expertise in precision medicine cancer diagnostics (IVD) and medical writing including Clinical Evaluation Reports (CER) and Standard Operating Procedures.

With a career spanning roles in pathology, marketing, business development, and commercialisation consulting, Chris excels in cross-functional team leadership, operations management, manufacture & logistics, stakeholder engagement, budgeting, finance and forecasting.

Additionally, he has experience in IP management, communications, digital marketing, and market research & data analytics. With a strong network of healthcare contacts, Chris has a proven track record of building stakeholder relationships and aligning teams to achieve strategic goals.

He has contributed to various medical device and pharmaceutical companies, including Livac, Commercial Eyes, Agilent Technologies, and Olympus Life Science.