Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are looking for you to get it registered in a number of other APAC countries such as Japan and Australia.
There are also plans to register in Europe and the US as well as a new digital health product that they are developing and you will be able to get involved with it all. The level of learning and breadth of knowledge you will develop in this role will be in demand by everyone.
The Regulatory Affairs Specialist will be responsible for:
Assessing quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR), EU-MDR, and ISO 13485.
Support product registration/submission activities and answer inquiries from regulators.
Ensure regulatory compliance at the company’s manufacturing sites regarding local and international regulatory legislation, standards, and guidelines.
The Regulatory Affairs Specialist will be/have:
Degree qualified in relevant field.
Experience in regulatory affairs for medical device products
Digital Health exp is a plus.
If you feel you would be suitable then, please apply now.