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LEARN MORECincinnati, Ohio
Malborough, Massachusetts
Manchester, New Hampshire
Burlington, Vermont
Posted: 03-Aug-22
Location: Ithaca, New York
Type: Full Time
Preferred Education: 4 Year Degree
Salary: $70,000-$90,000
Categories:
Salary Details:
Preferred Education:
Additional Information:
Internal Number: RS-01
Who we are looking for:
Transonic, the originator of innovative volume flow measurement technologies, is looking for a dynamic, critical-thinking, self-directed initiator who can be a key contributor in the company’s regulatory affairs department for our medical devices, life-sciences, and OEM markets. We are looking for someone with an understanding of FDA, EU and other key country’s regulatory requirements to support our worldwide product registrations. We are hoping for someone who thrives in a fast-paced environment while still being detail-oriented and who is able to think along with multiple projects and priorities.
Who we are and what we offer:
Transonic is a small family company of around 130 staff with big goals. Our sales/service divisions in Europe and Asia provide us with worldwide reach. We develop and pioneer innovative technologies and solutions, often the first of their kind, which help ensure that:
Several of our research and clinical products have gained worldwide gold-standard status, largely through their innovative nature, the reproducibility and accuracy of our measurements, and our robust product designs. We support our customers with top-notch training and support materials that demonstrate a deep understanding of our technology, and we go above and beyond to teach our users best practices and to help them implement our measurements. We are a tight knit group with a lot of long-term staff who believe passionately in our solutions and technology and because we are small, there is a lot of room for career growth and development. Decisions are made quickly as a group, and we work hard to make the engineering department an enjoyable place to work where staff feel that they are valued and can contribute as a part of our team. We offer competitive pay & great benefits, such as company paid 401k contributions, full, company-paid medical insurance, paid holidays, vacation and other benefits.
Primary Function
This position will support worldwide regulatory registrations for our current and future medical devices as well as support process compliance in conjunction with our engineering department. All candidates should have a depth of experience in applicable FDA and foreign medical device regulations, including ISO 13485 and FDA 21 CFR 820 and the EU MDR.
Duties and Responsibilities