Dr. Adelheid Schneider
Consultant in Regulatory Affairs and Quality, Coach
and Mentor
Dr Adelheid Schneider earned her Doctor of Science in cell biology and immunology from the University of Hohenheim/Germany and the Fraunhofer-Institute for Surface Technology.
With a background in biotechnology and cell biology Adelheid joined Roche in 1995. Within Roche, she worked in the field of research and development in protein chemistry and enzymology, quality assurance, quality control, documentation and regulatory affairs operation and policy. From 2017 to 2023 Adelheid was based in Singapore as Regional Head for Regulatory and Quality for Roche Diagnostics Asia Pacific where she had oversight of all outreach activities with global health authorities, industry associations and scientific organisations.
Adelheid offers services in consulting (regulatory and quality topics), training, coaching and mentoring.
Dr. Schneider has:
- 30+years of national, regional, or international professional experience working in the area of regulation of IVD medical devices within the national or regional regulatory authority and/or IVD Medical Device industry.
- Excellent regulatory and quality knowledge globally, especially EU, APAC, ME and Africa
- Extensive experience working with global regulatory agencies to support development and resolution of complex regulatory issues
- Strong Leadership skills - Coaching and mentoring (CPPC and ACC certified)
- Experience leading working groups within international forums and Industry Organisations (nominated as Chair for the IVD WG and Vice Chair in the Regulatory Leading Committee at APACMed from 2018 til 2023), and appointed as GHWP IVD WG2 Vice Chair in 2022)
Currently Dr. Schneider is the Vice Chair of the GHWP IVD WG 2 (Global Harmonisation Working Party), the executive deputy secretary general of the GHWP TC leadership team and the training hub co-lead of the GHWP capacity-building group. Additionally, Duke Core Centre of Regulatory Excellence appointed Dr. Schneider as Visiting Expert.
Key Services:
- Strong technical knowledge in IVD product manufacturing, and quality management systems (QMS).
- Strong technical knowledge in internationally recognised quality assurance standards and IVD medical device product regulation.
- Good communication and interpersonal skills to work in a multicultural team and maintain effective working relationships with recognised experts and stakeholders.
- Strong methodological and analytical skills to conduct research, identify and analyse literature relevant to the program area.
- Good planning and organisational skills with attention to detail
- Strong IT skills: Word, Excel, presentation software, databases
- Designing and developing learning content, assessments, learning experiences, and interactions to ensure the effectiveness of the learning course(s).
- Experience in working in collaboration with global forums and industry organisations, such as IMDRF, GHWP, AMDC, WHO, the World Health Organisation is essential in order to understand WHO's roles and core functions.
- Mentoring, Coaching and Training Skills (CPCC and ACC certificied)
