RegulatoryAffairsSpecialistII

**We are the people who give possibilities purpose** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. # Job Description Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist II is responsible for preparation of U.S and CE marking submissions/registration activities, along with supporting all other geographical regions registrations. In addition, this position will work cross-functionally to develop regulatory strategy across the product lifecycle. This role provides the flexibility to work on site 4 days weekly in Covington, and remotely Friday on a weekly basis. **Key responsibilities will include:** * Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents). * Prepare &/or revise STED technical files for CE marking activities and notified body interaction to support EU/MDR product maintenance, as required. * Provide support and guidance for post market activities including remedial actions, labeling. * Prepare and support 510(k) &/or change assessments, as required. * Limited travel required – 15%. To be successful in this role, you will work independently by applying your written and analytical skills to create technical documents, in some cases to cover design changes and change notifications for BD’s wide range of medical devices. You will also leverage your communication skills to work effectively w