SME Profile

Sabah Malek Senior Regulatory Scientist

Senior Regulatory Scientist in Voisin Consulting Life Sciences’ Cambridge office in MA, USA. She is responsible for multiple client projects involving the implementation of global regulatory strategies and submissions for the development and marketing of medical devices (MD) and on in vitro devices (IVD).

Sabah has various national and international submission experiences with MD and IVDs in the US, EU, Canada, and China. Her work in Quality Management Systems includes compliance with ISO 13485 and 21 CFR Part 820. Her expertise also includes knowledge of Clinical Laboratory Improvement Amendments (CLIA ’88) regulations in the US related to devices in laboratories. She is currently involved in the preparation and execution of various regulatory-related activities, especially in the US with the FDA include coordination and submission of Pre-IDE meetings, Establishment Registration, and evaluation of completeness of marketing applications.

Before joining VCLS, Sabah had graduated from Boston University with a Bachelors degree in Biology. Throughout university, she participated in research activities in a biomedical research institute which contributed to several publications. After graduation, she started work for an IVD manufacturing company in Boston, MA, USA as a Business Development Associate. Her responsibilities included educating Key Opinion Leaders about the advantages of using the device as well as developing new product lines. Soon afterwards, her work grew to include regulatory and quality responsibilities as Regulatory Affairs & Operational Manager. Her efforts also resulted in an ISO13485 certification, Health Canada license, and a revised 510(k) clearance. Sabah’s responsibilities also included complaint handling, label review, non-conforming material reports, vendor audits and assessments.