Get to know OrthoXel’s Quality Assurance & Regulatory Affairs Director Mark Moynihan
Mark how did you get into Quality and Regulatory Affairs?
After graduating with qualifications in Microbiology (BSc) and Bioinformatics (MSc) from University College Cork, I completed a course in Quality Assurance at the Cork Training Centre and as part of that course there was a work experience placement. My placement was with a start-up medical device company that was in the early stages of implementing a Quality Management System and developing a regulatory strategy to get their new medical device CE marked. After the placement ended, I was kept on as a Quality Engineer and worked with experienced QA/RA consultants to ensure readiness for the company’s initial certification audits and file reviews. I think I was very fortunate to get my start in Medical Device QA/RA in a start-up as it gave me exposure to all aspects of Quality Management Systems and applicable regulatory requirements, whereas gaining such a broad level of experience from an entry level position in a multinational medical devices company would be much less likely.
Since joining OrthoXel how has your role evolved?
In addition to the daily QA/RA tasks, a key focus is on ensuring that the company’s Quality Management System and Technical Files are compliant with the EU Medical Device Regulation which went into full effect last month. One aspect of my current role at OrthoXel that was new to me compared to my previous position is ensuring implementation of requirements relating to sterile medical devices, allowing me to put learnings from my Microbiology degree into practice but there has also been lots of new things to learn on that front!
Where do you see the greatest challenges in Medical Devices QA/RA over the next 5 years as OrthoXel expands commercially?
All medical device firms that market or plan on marketing their devices in the EU must navigate the EU’s new Medical Device Regulation which has upped the ante significantly compared to the Medical Devices Directive, for instance, by imposing stricter requirements for claiming equivalency to an existing CE-marked device in the absence of having clinical data from pre-market clinical studies. Another important challenge companies face will be getting Technical File reviews for CE-mark approval in a timely manner due to a significant reduction in the numbers of notified bodies certifying to MDR requirements and growing demand for those remaining.
Outside of your demanding and detailed role what do you enjoy spending your free time on?
Walking, reading and playing an occasional game of pool with friends.