Trajan Scientific and Medical (Trajan) has appointed Anne Marie Whalen, PhD as the Global Head of Regulatory Affairs, based in MA, USA. She will be overseeing Trajan’s Scientific and Medical regulatory affairs, including medical devices regulated in USA, Europe and Australia, and supporting Trajan's strategy for personalized, preventative, data-based healthcare in key markets globally.
Mr. Stephen Tomisich (CEO Trajan) said, “We are incredibly fortunate to have someone of Anne Marie’s experience and calibre join the Trajan team, progressing the next steps in our journey as we advance further into the regulated space.”
Dr Whalen has a strong background in the development of regulatory strategies to support the successful commercialization of medical device products. Her career spans more than 25 years in the pharmaceutical and medical device industries. As part of medical device commercial realization, she has worked with development teams in supporting in-vitro-diagnostics (IVD) and accessory kits through FDA approval in the USA, and conformity assessment to CE Mark in Europe. She also brings expertise to shape healthcare policy with extensive experience with global healthcare organizations, such as the World Health Organization, and industry advocacy groups.
In assuming the position, Dr Whalen has especially noted the significance of Trajan’s growing portfolio of innovative microsampling technologies to support patient-centric sample collection for remote bioanalytical applications "Microsampling opens up new opportunities for patient access to diagnostic and wellness testing, through ease-of-use sample collection with an expanding range of applications. This is particularly true for patients that have been marginalized in the healthcare system, and I feel privileged to participate with my Trajan colleagues to bring these products into the marketplace in a compliant manner."
Anne Marie will report to the Chief Corporate Systems Officer, Dr Rick Barber.
Trajan is a global developer and manufacturer of analytical and life sciences products and devices founded to have a positive impact on human wellbeing through scientific measurement. These products and solutions are used in the analysis of biological, food, and environmental samples. Trajan has a portfolio and pipeline of new technologies which support the move towards decentralised, personalised data-based healthcare.
Trajan is a global organisation of more than 650 people with seven manufacturing sites across the US, Australia, Europe, and Malaysia, and operations in Australia, the US, Asia, and Europe.