Medical Equipment - Cuttingsville, VT, US
Are you an overworked and under-appreciated Regulatory Affairs Manager? Do you have a demanding boss that treats you like a cost center? We are building the best medical device quality and regulatory consulting firm for start-ups. We hired our 10th full-time employee, but we plan to hire a new full-time, permanent regulatory consultant to join our team in 2022. We are looking for an individual that already has experience preparing medical device regulatory submissions. Previous 510(k) experience is required, but CE Marking and Canadian Licensing experience is a huge plus. 100% of our team works remotely from home or any sunny spot with reliable internet (no shoes required). If you are the lucky person to join our team, you will enjoy independence and autonomy without the stress of running your own business. You will also receive four weeks of paid time off in your first year, and five weeks of paid time off each year after that.We are a full-service QA/RA consulting firm that specializes in helping start-up medical device companies obtain 510(k) clearance, Canadian Medical Device Licensing, and CE Marking. We also help our clients establish new ISO 13485:2016 quality systems and obtain MDSAP certification. We love training, and offer training certificates for your continuing education. Every week we record new training webinars and YouTube videos. We also post a new blog every week on current quality and regulatory issues.
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