Meet Meiyi. A key member of our Quality Assurance and Regulatory Affairs Team, she works closely with Sheldon to make sure all Medmont products comply with the regulations required to be sold in the countries they’re marketed in. Keep reading to learn what Meiyi does at work and in her free time.
Tell us about your role as QA/RA Associate—what does it involve?
My role is made up of two specific parts: one is QA Associate and another one is RA Associate.
For the QA Associate part, I support implementing, managing and improving the Quality Management System for Medmont (which is under the frame of ISO 13485 and MDSAP).
For the RA Associate part, I support Medmont to fulfill our regulatory obligations. This includes introducing new regulation requirements into the Quality Management System (QMS), regulatory clearance for required markets, post market surveillance reporting and more.
How long have you been at Medmont, and what do you like most about working here?
I have been at Medmont for 2 years and 3 months. The thing I love most about working here is the challenge of this position and cross-function collaboration with different departments.
Dealing with different country’s regulations is really challenging, which I like, although Medmont’s products are classified as low to medium risk devices.
What’s the best thing about working with your manager, Sheldon?
Sheldon is one of the best professionals I have met. His logic is clear and convincing, especially in the Active Medical Device area. I really appreciate his mentoring during my job in Medmont.
What attributes do you need to be good at your job?
To be good at this role, I think you need, at least, the following attributes:
- A high level and deep understanding of the systems, processes and procedures in the medical device industry.
- Training in the relevant QMS, such as ISO 13485/ ISO9001.
- Problem-solving skills.
- Basic understanding of the frame and structure of the regulations, e.g. EU MDR, TGA, FDA, Health Canada, ANVISA, NMPA.
- To understand strategy behind the compliance route and submission chosen.
What gives you the biggest sense of achievement in your role?
Receiving the regulatory marketing clearances we expect, one by one, and receiving confirmation of successful registration/listing gives me the biggest sense of achievement in my current role.
What do you enjoy doing when you’re not working?
I love to do Pilates when I am not working. Previously I had shoulder and neck pain frequently, but since I started doing Pilates regularly, the pain disappeared and never came back. Also, every time, by doing this sport, I can clear my mind easily. So, my friends, if you like it too, come and join me—let’s keep our body and mind healthy together.
What are you reading, watching or listening to at the moment?
I recently read a book [丰盈心态养孩子 (Raising children with an abundance mindset). I’m not sure whether my English translation of the book’s name is correct, but this book gives me insights about how to recognize ourselves and cope with our relationship with our kids as a mindful, peaceful parent.
For watching, I always follow my son Adam’s favorites. He is a big AFL fan who supports Geelong Cats and a fan of soccer—he supports Argentina. As long as the show is related to footy or soccer, he won’t miss it. Our living room turns into his soccer practice place!
You’re from China: what are you most looking forward to on your upcoming trip home?
This is the first time my whole family have had a holiday back to China since we migrated here to Melbourne. Time flies, we’ve already been here more than 4 years.
Delicious food is what I am most looking forward to. Besides this, we also have some exciting plans:
- To see cute Panadas in Sichuan Province.
- To climb up the Great Wall.
- To Disneyland in Shanghai.
- Enjoy family and friend’s time.
I am curious what kind of impression this trip will give Adam.
Would you like to work at Medmont? Email firstname.lastname@example.org to enquire about joining the team!