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Medical Device Regulator

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  1. What is your profession/industry? Medical device/medical equipment What do you do? Document control and regulatory affairs. What skills/experience do you need? Experience I actually started out as a receptionist, and have stayed with the company for 12 years, I’ve eventually learned our products and procedures to move up to my position. Technical skills (e.g. education, programming languages, etc.)Professional skills You don’t technically need a degree, but you do need to do training and certifications on the Standards to qualify for the position which you can do online. Technical wise, you’ll be doing a lot of computer office work so you need to be familiar with the regular software programs like Microsoft, Adobe, and any other programs your company uses. Professional skills Understand the domestic and international standard requirements (you learn when you do the certification classes). You need to be organized because you and the company will be audited by regulatory bodies like the FDA to make sure that your products are safe to be in the market. Attention to details is important for both titles, one is making sure all records are accurately kept and the other makes sure that all procedures and being followed properly. What inspires you about your work? (e.g. do you appreciate the challenges, problem-solving, management, your impact on a corporation/team) The industry changes to society needs. So there’s always something to learn. What I like the most about my job is researching requirements for each country because most countries have different sets of requirements. One of the biggest challenges is applying the standard to your product. There are regular standards that is kind of like a one-fits-all thing, and you have to figure out how your company/product procedure meets that requirement. What kind of person do you think it takes to do what you do? Someone who is good with details, being organized, doesn’t shy away from mundane and tedious jobs, and wants to understand standards. Someone who basically writes the procedure for producing a product.
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