Brad Sheehan

Brad SheehanBrad Sheehan (R.N., BNurs, GradCert Crit Care, GradDip Bus(Mgt), CCRA, GAICD) is an Australian Registered Nurse with experience in Critical Care and Hospital Management. He holds a Bachelor of Nursing, a Graduate Diploma in Critical Care and a Graduate Diploma in Business Management. Brad has been involved in Clinical Trial Project Management and Medical Device Regulatory Affairs since 2001 where he transitioned from the hospital setting to the medical device industry, working for Q-Vis Limited.

In 2002 he moved to Clinical Cell Culture Limited, an Australian based Tissue Engineering Organisation where he held the Vice President of Quality and Regulatory Affairs position, taking products through global Regulatory approval processes, implemented and maintained Quality Management Systems in offices across two continents, and managed the organisations international Clinical Trial programs. After 6 years at Clinical Cell Culture Brad became a freelance consultant to the medical device industry where, in 2008, he first started working with Five Corners, becoming a full time employee in early 2010. He has since been supporting our clients in regulatory and reimbursement efforts to get their products to market in both Australia and New Zealand. He has also continued to assist clients implement and maintain their Quality Management Systems to ISO 13485, and provided guidance and management support of risk management planning and reporting to ISO 14971.

One of Brad’s key responsibilities at Five Corners is working with clients to undertake their clinical research activities in Australia. Brad is well versed in supporting clients in planning their clinical trials being involved in activities such as protocol and budget development, drafting of case report forms, preparing applications to ethics committees, performing clinical trial training at investigative sites, monitoring clinical trials and regulatory reporting.

Brad has additional expertise in quality systems auditing, sterilisation validation of medical devices and the international regulation of medical devices and cell therapies. He has many years of experience working in the Regulatory arena with the Australian Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe, assisting clients prepare their regulatory strategies and preparing and submitting medical device and IVD applications, documentation to support application audits, and full conformity assessment applications.

Brad has undertaken continued industry education in Project Management, Quality Systems, Medical Device Risk Management, International Regulatory Affairs and Good Clinical Practice. He has also been a guest speaker on multiple occasions at RAPS, ARCS and AusMedTech conferences in Australia and the US, and has been published in the RAPS Regulatory Focus Magazine on European Regulation of Cell Therapies. Brad serves on an Australian based ethics committee, is an accredited Clinical Research Associate with the Association of Clinical Research Professionals and a Graduate of the Australian Institute of Company Directors.