Natalie Batty has joined Qserve Group as a consultant where she is part of the IVD team. With the experience in preparing IVD documentation for US, Canadian and European regulatory agencies she can, together with the other IVD specialists, make a valuable contribution to our global customers.
Natalie has over 6 years of regulatory and clinical affairs experience working with in vitro diagnostics. She has completed multiple FDA submissions (de novos, 510ks, and Emergency Use Authorizations) and has managed labeling and post market surveillance vigilance activities. Additionally, she has experience with quality management systems, risk management, and is a certified lead auditor. Natalie has a strong technical scientific background with a Bachelor’s degree in biology and chemistry, and a Master’s degree in Public Health from Westminster College in Salt Lake City, Utah USA.
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 in medical devices. Check our current vacancies.