Senior Regulatory Affairs Specialist - Urology

A minimum of a Bachelor's degree, preferably in a scientific or technical discipline A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices Demonstrated experience of regulations applicable to the conduct of clinical trials Prior experience with regulatory submission writing Demonstrated understanding of product development process and design controls Demonstrated knowledge of FDA, EU and/or international regulations Ability to manage several projects simultaneously Effective research and analytical skills Excellent written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision Strong interpersonal and influencing skillsProficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)