Michael Tormey, Certificate in Medical Technology Regulatory Affairs and Quality
Name: Michael Tormey
School: St. Mary’s, Boyle
What key skills did you learn while studying at IT Sligo that have influenced your career?
Detailed Knowledge of EU and U.S Medical Device directives & regulation – Greater understanding of Quality Managements Systems. – Risk Management including the use of risk management tools to complete risk assessments for medical devices. – Design and Process Validation Systems & Equipment/Instrument Calibration. – Conducting Quality Audits. – Technical Writing.
Can you share some detail of your career path to date:
I completed a level 7 degree in Analytical Chemistry in Athlone IT and joined ELAN pharmaceutical after graduating in 1997. I spent 2 years working as a raw material analyst, performing incoming inspections on the raw materials used in the manufacturing of the various pharmaceutical products ELAN produced. I joined Abbott’s Diagnostics business in Sligo in 2000 where I took up a role as a QC analyst, responsible for customer release testing of the finished product and In-process batch record auditing. Since joining, I have changed roles several times. I transitioned from a QC role to a process specialist role, responsible for the technical support of in-process material and instrument platform training role out. I moved from this role to a laboratory supervisor role. This involved managing a team of laboratory personnel and maintaining the technical manufacturing and QC testing schedules. I maintained this position for several years before i moved into the change control department, where i was responsible for management of the area, which included the change control team and the various workstreams associated with change requests. My current role is a design plan Co-Ordinator within the in vitro diagnostic regulation (IVDR) transition project team, where I am responsible for authoring and routing electronic design plan packages which align product compliance to the new EU In vitro diagnostic regulations.
What does your current role involve?
My current role involves assembling cross functional teams (CFT’s) to assess IVDR change requirements, scheduling CFT meeting, authoring electronic design plan packets, routing design plan packets for approval and conducting design and pre-market reviews for the transition of our products from the existing EU In Vitro Diagnostic Directives (IVDD) to the new In Vitro Diagnostic Regulations (IVDR).
What advice would you share with our current students considering a career in your field?
If like me, you have been out of college a long time and you are not in a regulatory affairs role then I would recommend completing the level 8 regulatory affairs course offered by IT Sligo in conjunction with NUIG. I am currently completing the Sligo/NUIG MSc in regulatory affairs and have found the level 8 post-graduation regulatory affairs course a great foundation for progressing into the MSc course. Completing the level 8 regulatory affairs course also gave me confidence to enter the masters program.
What did you like best about your course?
I like the idea of continuous assessment. I believe that under this approach you obtain a deep understanding of the topic or module that a once off exam type of scenario can’t give you. Continuous assessment will reward your efforts if you work hard and employ a good time management strategy. I also like the idea of independent learning and independent thinking which is encouraged in this course. I believe that this will empower the graduate to participate or even lead regulatory projects within their organisation. I also found the course content very relevant to my workplace. As i progressed through the various modules i could related the learning material back to specific processes within my workplace environment.
What did you like best about IT Sligo?
I liked the flexibility that IT Sligo online learning provided. Recorded lectures could be reviewed as often as needed, addition reading material links were provided and promoted, and assignment briefs and due dates were clearly laid out from the start of the course. Lecturers were also available for discussions outside of lecture hours if additional supports needed.
What advice would you give a first-year student starting in IT Sligo?
I would advise students to manage their time well. Have a study plan which has an optimal work/life balance and stick to it as closely as possible. If possible, try and get some work experience in your chosen field while you are studying. In my experience the course material is very relevant to the industry I work in, so observing my learning outcomes being applied in the workplace has really helped me understand the context of my course.
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