Principal Regulatory Consultant
NAMSA
Rachel is a Principal Regulatory Consultant for NAMSA, providing strategic expertise to clients regarding their regulatory and clinical needs, undertaking gaps assessments and drafting MDR submission documents. Rachel has over 15 years of experience in the pharmaceutical and medical device industry. She has recently moved to consultancy having been at BSI as a Senior Technical Specialist and Scheme Manager for 7 years working under both the MDD and MDR. Rachel has conducted MDR reviews for Class IIa to Class III wound devices and has an auditing background in general, non-active devices with a speciality in wound care and sutures. As a Clinical Evaluation Specialist at BSI she has reviewed CERs and SSCPs against the MDR requirements.
Prior to BSI, Rachel worked in industry for 8 years in Product Development of Metered Dose Inhalers and Nasal sprays, including running pharmaceutical development studies for the characterisation of the MDI/nasal spray to meet the EMEA and FDA requirements. Latterly she moved into Product Development of wound care devices, where she developed dressings from concept through the New Product Introduction (NPI) process to commercialisation. Her area of expertise was Design Control, and Risk Management, with responsibility for the development of the overall Technical Documentation for submission to the Notified Body.
Rachel has a biological background with a BSc (Hons) in Biochemistry from the University of Leeds and a PhD in Immunology and the role of cytokines in the degradation of the abdominal aortic aneurysmal wall from the University of Leicester.
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Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST