Becki Hiebert lives and works on Treaty 6 territory, a traditional gathering place for diverse Indigenous peoples, including the Nehiyaw (Cree), Niitsitapi (Blackfoot), Nakota Sioux (Stoney), Dene, and Métis. Her family’s roots are in Treaty 1 territory (Steinbach, Manitoba), where settlers like her ancestors were invited to live on stolen land. 

Becki is a quality and regulatory consultant who helps early-stage life science companies bring medical technologies and therapeutics from concept to clinic to market. Her expertise includes developing quality management systems, preparing and executing clinical studies, and supporting regulatory submissions. 

With over a decade of experience in the life science industry, Becki has contributed to a range of projects spanning laboratory research, clinical operations, quality assurance, and regulatory affairs. Her clinical experience includes evaluating study sites, managing deviations and changes, implementing study management software, developing key clinical documents, and preparing ITA submissions and reports to Health Canada. She has also participated in meetings with FDA and Health Canada to discuss clinical study design and regulatory strategy. 

Before founding BH Quality Management Consulting, Becki worked in research, quality control, quality assurance, and regulatory roles with both global firms and emerging startups. She holds a BSc in Chemistry from the University of Winnipeg and an MBA from the University of Alberta. 

Becki’s approach is hands-on and collaborative, helping teams design systems that simplify compliance and align regulatory expectations with product innovation. She is active in Alberta’s life science and innovation communities, and mentors through MedTech Women and Regulatory Affairs Professionals Society (RAPS). Her work is guided by authenticity, integrity, and curiosity, and by a deep conviction that quality and regulatory practices are essential to improving patient outcomes.

Services Offered:

• Regulatory strategy development and submissions support 

• Quality Management System (QMS) design, implementation, improvement 

• Clinical study documentation and submissions support 

• Training, mentoring, and team development