Regulatory Affairs Specialist, P3

Deliver what matters and focus on meaningful outcomes Your responsibilities will include: Prepare and submit EU MDR Technical Documentation to Notified Bodies in accordance with sampling plan and recertification requirements. Collaborate with Medical Safety, Clinical Risk, R&D, and Design Assurance to prepare and submit Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs) to Notified Bodies. Support operations and sustaining teams by conducting and documenting EU, US and international regulatory impact assessments for supplier, manufacturing, and product design changes. Provide support for regulatory audits and inspections, as required. A minimum of a bachelor's degree A minimum of 5 years of EU and US medical device regulatory affairs experience Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings Demonstrated experience authoring/supporting regulatory submissions for EU, such as MDR Technical Documentation and General Safety and Performance Requirements Checklist. Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat Strong technical, research and problem-solving skills Ability to articulate complex ideas clearly both verbally and in writing Team player with excellent interpersonal skills Demonstrated ability to effectively manage multiple projects and priorities Works well in fast-paced cross-functional team environments