Lindsay Kleinwaks serves as a Regulatory Affairs Manager at Thermo Fisher Scientific, where she plays a pivotal role in navigating the complex regulatory landscape for in vitro diagnostic (IVD) products, particularly companion diagnostics (CDx) in oncology. With a Ph.D. in Microbiology and Immunology, Lindsay brings...
Lindsay Kleinwaks serves as a Regulatory Affairs Manager at Thermo Fisher Scientific, where she plays a pivotal role in navigating the complex regulatory landscape for in vitro diagnostic (IVD) products, particularly companion diagnostics (CDx) in oncology. With a Ph.D. in Microbiology and Immunology, Lindsay brings over six years of specialized experience in the medical device industry, allowing her to develop and execute sophisticated regulatory strategies that ensure compliance with both US and EU regulations, including the In Vitro Diagnostic Directive (IVDD) and the In Vitro Diagnostic Regulation (IVDR).
In her current role, Lindsay has cultivated a deep understanding of the regulatory requirements that govern Class III companion diagnostics throughout their product life cycle. Her expertise encompasses critical investigation and interpretation of regulatory guidelines, enabling her to effectively communicate complex information to cross-functional teams and stakeholders. Lindsay's proficiency in molecular biology and immunology, combined with her quantitative research skills, positions her as a key contributor to the development of innovative diagnostic solutions that enhance patient outcomes in oncology and other therapeutic areas.
Key projects under her leadership include the successful submission of regulatory filings for novel CDx products, where she has streamlined processes to expedite time-to-market while ensuring adherence to stringent quality standards. Lindsay's commitment to excellence in regulatory affairs is further exemplified by her collaborative approach, working closely with clinical trial teams to align regulatory strategies with scientific objectives. Her extensive knowledge of biotechnology and medical microbiology not only enhances her regulatory acumen but also fosters a culture of compliance and innovation within her team at Thermo Fisher Scientific.
