Sr. Regulatory Specialist

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, including NPD initiatives and change assessments
• Drive process improvements, mentor team members, and support audits, regulatory inspections, and cross-functional initiatives (e.g., Kaizen events)

Minimum Requirements:

• Bachelor’s degree required, preferably in a scientific discipline or regulated industry; ability to travel up to 15% as needed
• Experience authoring and supporting U.S. (510(k)), EU (Tech File/STED), and international regulatory submissions
• Proven ability to update and maintain STED files for CE marking and support notified body interactions under EU MDR
• Strong knowledge of U.S. and European medical device regulations, including familiarity with IEC 60601 standards and post-market regulatory requirements
• Demonstrated ability to manage multiple projects, maintain strict confidentiality, and provide regulatory strategy, labeling review, and post-market guidance

Preferred Requirements:

• 4 - 7 years experience in medical device (to include some experience within medical device); experience in areas of product registration, new product development and product changes highly 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).
• Must be able to work in fast paced and complex environment juggling various priorities.
• Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.
• Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.