Sr. Regulatory Affairs Specialist

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.

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 Senior Regulatory Affairs Specialist 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 help support RA management. This role provides the flexibility to work on-site 4 days weekly in Covington, and remotely Friday on a weekly basis.

Key responsibilities

• 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 & 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) & change assessments, as required. Limited travel required – 15%.

Minimum Requirements

• Education: Bachelor of Science (BS) degree required, preferably in a scientific discipline, engineering, or other regulated field.
• Experience: Minimum 4 years of Regulatory Affairs experience within the medical device industry. Experience supporting product registration, regulatory compliance, and quality system activities for medical devices.
• Technical Knowledge: Working knowledge of U.S. FDA regulations, including 21 CFR Part 820, and European Medical Device Regulation (EU MDR).
• Experience with: U.S., EU, and international product registration activities. Medical device quality systems and regulatory compliance. Preparation and submission of FDA 510(k) premarket notifications. Development and maintenance of technical documentation, including STED/Technical Files. Interactions with regulatory authorities and/or EU Notified Bodies.

Core Competencies

• Demonstrated ability to support products throughout the product lifecycle, including product development, design changes, and post-market activities.
• Experience developing regulatory strategies, conducting change assessments, and managing regulatory deliverables and timelines.
• Strong technical writing skills with the ability to prepare clear, accurate, and compliant regulatory submissions.
• Ability to maintain confidentiality when handling regulatory, clinical, and business-sensitive documentation.
• Strong organizational and project management skills with the ability to prioritize multiple projects and meet deadlines.
• Self-motivated with the ability to work independently, exercise sound judgment, and take ownership of responsibilities.
• Effective written and verbal communication skills with demonstrated success working on cross‑functional teams.

Preferred Qualifications

• Education: BS degree specifically in a Scientific Field (such as Biology, Chemistry, Biomedical Engineering).
• Certification: Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
• Product Knowledge: Familiarity with ClassII medical devices, particularly in the urology or acute care hospital setting.
• Advanced Skills: Experience leading regulatory activities on cross‑functional product development teams. Ability to influence project teams and communicate regulatory risks and mitigation strategies. Strong analytical skills for evaluating technical data and determining regulatory impact. Excellent communication skills for interactions with regulatory authorities, Notified Bodies, auditors, and cross‑functional stakeholders.

Work Arrangement

Ability to work on-site in Covington 4 days per week with remote work on Fridays.

Travel

Willingness to travel up to 15% as needed.

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

Equal Opportunity Employer

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.

Primary Work Location

USA GA - Covington BMD Additional Locations Work Shift US BD 1st Shift 8am-430pm (United States of America)

Company Culture

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

Equal Opportunity Employer (duplicate)

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.