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Medtech lessons from the Trenches: Ann's RAQA journey to Compliance
When Ann started her Bio-engineering degree, she had a clear goal: specialize in medical technology. After completing her PhD, she found herself at a crossroads. Her ambition was to enter the Medical technology sector, leveraging her network within the industry and her scientific background.
During a conversation with a recruiter, Ann received a new suggestion: Regulatory Affairs and Quality Assurance (RAQA). The term was unfamiliar but curiosity piqued and Ann began to explore the realm of RAQA, discovering its potential to align with her aspirations.
Ann's journey from academia to professional life took an unexpected turn as she delved into the world of RAQA. The recruiter's insight, though initially puzzling, sparked her interest. She applied for a position as Compliance Specialist and was lucky enough to start in a startup. Ann could feel the hands-on mentality which she experienced and loved during her PhD. The "WE" was bigger than the "I". Ann delved into the realm of QA, acquainting herself with regulatory requisites through practical experience. Guided by a seasoned manager, she imbibed these insights "on the job" and being part of a smaller organization taught her how to be flexible within the framework of regulations.
This value remains deeply ingrained, a testament to her conviction. Ann recognizes the paramount importance of flexibility within the rigidity of regulations. In her eyes, no two companies march in perfect unison in their operational cadence, yet each must navigate the same landscape of standards and regulations.
There are no two companies identical in their way of working, and yet they all have to comply with the same standards and regulations. From an engineering standpoint, it's clear that there are several solutions to a problem, and this is also true when implementing a Quality Management System.
Moving on to a multinational organization, again she learned different aspects of a larger business. Other challenges for the implementation of a QMS arose, dealing with different regulatory requirements from different regions of the world, encountering differences in approach... and yet, they all had to comply with the same kind of standards and regulations.
The experience she gained came from the field. From working with consultants, from learning by doing. This is what we can also see happening with many startups that grow with Matrix Requirements. Brilliant minds with brilliant ideas to help improve patients' lives.
However, bringing those solutions to the market also requires insights into regulatory requirements. If you’d like to learn more about the journey of the team at Matrix Requirements, and how we can help you get your Medical Device to market faster, sign up to our newsletter here.