Job title, company, and location:
Principal Consultant – Medical Devices Regulatory & Quality
Co-founder and non-executive director of Market Access (AUS) Pty Ltd
Biography:
Val Theisz is a regulatory affairs professional with over 20 years of experience in medical devices of all risk classes, including life-sustaining, high-risk active implantables, and software as medical devices (SaMD) using artificial intelligence (AI) algorithms. Val has a Masters degree in electrical engineering and holds Regulatory Affairs Certification credentials for EU and US regulations (RAC EU, RAC US) from the US-based Regulatory Affairs Professionals Society (RAPS). Val is one of the few RAPS Fellows based in Australia. Before moving to Australia in 1999, Val worked for seven years with a major EU Notified Body as a test engineer, QMS auditor and technical certifier. In Australia, Val held regulatory and QMS management positions in both established and start-up companies covering the entire product lifecycle: defining regulatory strategy; verification and validation (V&V) to international standards; clinical trials for high-risk innovative medical devices; submissions preparation and successful approvals in established markets – EU MDR (CE Marking), U.S. FDA 510(k) and PMA, TGA registration; and post-market compliance. Val has also been the Director of Regulatory & Clinical Affairs, Code of Practice with the Medical Technology Association of Australia (MTAA), leading industry advocacy initiatives with the TGA and the Australian Department of Health.
Areas of expertise:
- Establishing audit-ready QMS for medtech start-ups, remediation of ineffective/ inefficient QMS
- Defining regulatory strategy for medical devices in key markets
- Preparation of assessment-ready technical documentation
- Hands-on support during audits and submissions assessment by regulatory authorities
- Preparing rationale in response to deficiencies raised by auditors/ assessors
- Ongoing compliance support, assessment of changes to the design of medical devices
Regulatory jurisdictions covered:
Australia, USA, EU, other jurisdictions following IMDRF guidelines
Education:
MSc in Electrical Engineering from UPT Universitatea Politehnica Timişoara, Romania
Certifications:
RAC EU and RAC US Certifications by RAPS (Regulatory Affairs Professionals Society) since 2001 and 2002, respectively, and RAPS Fellow since 2010
Publications:
- Book ‘Medical Device Regulatory Practices: An International Perspective’ – Publisher: CRC Press
- Published articles in the RAPS Focus magazine (June 2012; April 2003; July 2002), and the UK Journal of Medical Device Regulation (August 2012; Feb 2009).
- Served on the RAPS Examination Committee for the RAC EU Exam for the max of two terms between 2002 and 2008.
Professional link:
LinkedIn: https://www.linkedin.com/in/val-theisz-9191305/
