Qserve Group is pleased to announce that Jude O’Donnell has joined the in vitro diagnostic (IVD) team where she will support IVD/CDx design, validation & regulatory submissions. Jude is based in Northern Ireland.
Jude has over fifteen years of experience in the IVD industry, specializing in the development, validation, and regulatory approval of clinical trial and companion diagnostic (CDx) assays. Within Qserve, Jude is a Principal Consultant within the IVD Team, supporting Qserve’s IVD clients to access global markets.
In former positions, Jude was a research and development team lead, IVD program lead and eventually held the role of Global Head of Regulatory Strategy, responsible for defining and evolving company IVD/CDx regulatory strategy in support of pharmaceutical partners’ drug development plans across a range of therapeutic indications and for regulatory submissions throughout the IVD product’s lifecycle.
Qserve is happy Jude has joined the team as she can share her knowledge with, and draw on her experience to support our customers in the IVD industry.
There’s a personal profile
available on this website where Jude explains more about her experience and her core competencies.About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO, and quality services.
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, or auditing to support manufacturers or distributors of medical devices and in vitro diagnostics. Check our current vacancies