Regulatory Affairs Manager I

Demonstrate people leadership commitment through coaching, meaningful conversations, career development, driving continuous improvement, enhancing leadership capability and leading inclusively. Establish and lead a Regulatory Affairs Operational Excellence team which will support EU MDR maintenance activities for the IO&E product portfolio. Provide training and guidance to employees on EU MDR maintenance activities to ensure continued compliance and audit readiness Provide training to new and junior employees on performing and documenting regulatory affairs assessments for supplier, manufacturing and design changes. Provide guidance to employees on the development of global regulatory affairs strategies for new product development projects. Perform regulatory affairs management review of submissions to regulatory agencies Attending monthly Notified Body meetings on behalf of the IO&E division. Oversee audit preparation activities and serve as the primary point of contact during audits. Conduct weekly one‑on‑one meetings with direct reports and lead structured quarterly development conversations. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. A Level 8 Honors Bachelor's Degree STEM 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 a variety of regulatory submissions for US and EU, such as 510(k)s and MDR Technical Documentation 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