Regulatory Affairs Specialist II

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 onsite 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.

Minimum Requirements:

• Education: Bachelor’s degree
• Experience: 2+ years of experience in Regulatory Affairs
• Medical Device Experience: 1 year of experience with medical devices
• Core Competencies:
  • Ability to provide regulatory support through the product life cycle on product project teams (developing regulatory strategies, change control assessments, timeline development, and reviewing submission-related documents)
  • Ability to update STED technical files for CE marking activities and notified body interaction to maintain EU/MDR product registrations
  • Ability to maintain confidentiality when dealing with regulatory and clinical documentation
  • Ability to prioritize and handle several projects concurrently
  • Self-motivated with ability to work independently and take ownership of responsibilities
  • Knowledge of U.S. and European medical device regulations
  • Technical writing skills and proficiency at compiling successful submissions for the appropriate audience
• Travel: Willingness to travel up to 15% (limited travel required)

Preferred Qualifications:

• Bachelor of Science (BS) degree or higher; preferably in a Scientific Field, Engineering or Regulated Industry
• Experience in product registration, compliance, or quality systems
• Experience supporting 510(k) submissions
• Experience supporting Tech File/STED File submissions
• Regulatory Affairs Certification (RAC)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.