Regulatory Affairs Spec - US, EU Med Devices
We have an immediate opportunity for a Regulatory Affairs Specialist in the Sandy, UT area. The Regulatory Affairs Specialist will represent regulatory affairs on new product development teams, sustaining engineering teams, and other product development initiatives. This position will provide these teams with strategic and tactical guidance regarding submission requirements to support product approvals in the US and EU.
In addition, this individual will liaise with our client's regulatory professionals outside of the US and EU to determine product approval requirements, globally, and communicate these requirements to the product development teams. The Regulatory Specialist will create regulatory strategies, review and approve labeling/promotional/advertising materials, ECOs, PDNs, as well as appropriate regulatory submissions and interact with health authorities to obtain and maintain product approvals in the US and EU.
In addition to prior US and EU regulatory submission experience for medical devices, this position requires an BA/BS degree. Preferred education/experience areas include health care, clinical, engineering, physical, biological, and regulatory sciences, potentially coupled with advanced degrees (MS, MBA, PhD, etc.) and certifications (RAC, CQA, etc.)
For immediate consideration please contact:
UpStream Global Services
UpStream Global Services - 19 months ago
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