Job Description
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 with internal customers and team members as well as external auditors. Education and Experience required:
BS required, preferably in a Scientific Field or Regulated Industry 2+ years experience in Regulatory 1 year experience with medical devices Experience in areas of product registration, compliance or quality systems highly preferred Experience supporting 510(k), Tech File / STED File submissions preferred. Regulatory Affairs Certification (RAC) preferred. Must demonstrate ability to provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission related documents) Update STED technical files for CE marking activities and notified body interaction to maintain EU/MDR product registrations. Must be able to maintain confidentiality in dealing with regulatory and clinical documentation Must be able to prioritize and handle several projects concurrently. Must be self-motivated by working independently and having the ability to take ownership of their responsibilities. Must have knowledge of the U.S. and European medical device regulations. Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience. Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers . Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location USA GA - Covington BMD Additional Locations Work Shift
