Sr.RegulatorySpecialist

**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 Home and Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, along with supporting all other geographical region 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. 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 with internal customers and team members as well as external auditors. **Key responsibilities will include:** * Lead regulatory strategy and lifecycle support for product project teams, including change controls, timelines, and submission document review * Prepare and maintain STED technical files to support CE marking and ensure compliance with EU MDR requirements, including notified body interactions * Provide regulatory guidance for post-market activities such as remediation actions and labeling updates * Lead and support U.S., EU, and international submissions, incl