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 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 onsite 4 days weekly in Covington, and remotely Friday on a weekly basis.

• 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 and/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 and labeling.
• Prepare and support 510(k) & change assessments, as required.
• Limited travel required – up to 15%.

• Education:
  
  Bachelor’s degree
• Experience:
  
  2+ years in Regulatory Affairs
• Medical Device
  
  Experience:
  
  1 year with medical devices

• 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.

Willingness to travel up to 15% (limited travel required).

• 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).

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.

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