IVD, Regulatory Affairs & Clinical Affairs
Natalie joined the Qserve Group early 2022 as a consultant on the IVD team and is based in Germany.
Natalie about working at Qserve
I enjoy contributing to the improvement of diagnostic and medical devices which support individual patient experiences as well as strengthen our overall global public health systems. The regulatory field is dynamic and constantly evolving and I like addressing the complexity of the field with Qserve customers.
I am excited to be part of Qserve’s global team and learn from my coworkers’ broad professional experience across the field.
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 prepared IVD documentation for Canadian and European regulatory agencies.
Natalie started her career in Research and Development working with PCR-based in vitro diagnostic devices for infectious disease testing. She transitioned into the regulatory affairs realm, eventually serving as a regulatory affairs manager for a medical device manufacturing company. In this role, she was responsible for the preparation and management of US regulatory submissions, labeling, and post market surveillance and vigilance. She has extensive experience with quality management systems, risk management, and has completed lead auditor training for ISO 13485. Natalie also has experience with IVD clinical evaluations. She is well-versed in ICH-GCP (Good Clinical Practice) and IVD clinical trial set-up and monitoring activities.
She has a strong technical scientific background with a Bachelor’s degree in biology and chemistry, and a Master’s degree in Public Health.
The key expertise areas of Natalie:
- Communication with competent authorities for registration of products (FDA, Health Canada) to ensure compliance with applicable regulations
- FDA presubmissions and preparation of IVD submissions (such as 510ks and de novos)
- Application of 14971 Risk Management Standard including hazard analysis and risk mitigation application
- Implementation and management of Post Market Surveillance and Vigilance (PMS, Field Actions, Adverse Event Reporting)
- Hands-on experience in supporting product design development and application of design control principles for IVDs
- Advising on design controls, user needs, requirements, specifications, risk analysis and verification of in vitro diagnostic products
- Familiar with practical application of 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971
- Expertise in clinical research design and implementation
- Clinical writing experience (study protocols, CRFs, informed consent)
- Management of IVD clinical evaluations
- Knowledge of ICH-GCP (Good Clinical Practice) and clinical trial monitoring activities
- Quality Management System Experience
- Languages Spoken: English (Native Speaker), Spanish (Fluent)