Ms. Hiebert’s quality and regulatory compliance experience will be valuable to medical device companies developing quality management systems to be compliant with ISO standards and EU MDD/MDR requirements.
WASHINGTON (PRWEB)
June 08, 2022
NDA Partners General Manager, Eric Fish, announced today that Becki Hiebert, a quality and regulatory compliance professional, has joined the company as an Expert Consultant. Ms. Hiebert has more than 10 years of experience supporting medical device and pharmaceutical companies with GMP, GDP, and regulatory compliance. She has experience developing, implementing, and maintaining quality management systems, ISO 13485, 21 CFR 820, MDSAP, and EU MDD/MDR standards, conducting audits to ensure compliance, and providing training and support on quality systems.
Prior to joining the company, Ms. Hiebert served as QMS Lead at Circle Cardiovascular Imaging where she was responsible for maintaining and optimizing the medical device Quality Management System to be complaint with ISO and EU MDD/MDR requirements. She also served as Regulatory and Quality Manager with Nanostics and in quality assurance and research roles with Gilead Alberta.
According to Ms. Roberta (Bobbi) Druyor-Sanchez, Manager of NDA Partners’ Quality Management Systems and Quality Systems Regulation practice, “Ms. Hiebert’s quality and regulatory compliance experience will be valuable to medical device companies developing quality management systems to be compliant with ISO standards and EU MDD/MDR requirements. We are pleased to welcome her to NDA Partners.”
Ms. Hiebert earned her MBA from the University of Alberta located in Edmonton, Alberta, Canada and bachelor’s degree in chemistry from University of Winnipeg in Winnipeg, Manitoba, Canada.
About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Contact
Eric Fish, General Manager
Office: 540-738-2550
FishEric@ndapartners.com
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