Senior Regulatory Affairs Specialist

Job Description Summary

The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Urology and Critical Care Business unit will work on regulatory strategy and submissions for urinary devices, responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in both the U.S. and Europe. The Senior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process addresses all regulatory requirements and objectives of the business.

The incumbent should have proven leadership and success working in cross‑functional teams and will perform crucial duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

• Regulatory support through the product life cycle and a core team member on project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission‑related documents).
• Represents RA and demonstrates leadership in product development team(s). Responsible for completion of regulatory strategies, review and approval of design control‑related documents.
• Lead cross‑functional team in preparing and implementing submissions to the US FDA with a focus on Class II products. Act as liaison with FDA regarding product submissions.
• Lead cross‑functional team in preparing and implementing technical files for submission to European Notified Bodies. Act as liaison with Notified Bodies regarding product submissions.
• Assess necessity for reporting changes to FDA for device modifications. Prepare robust justifications for changes that do not require notices. Address and resolve requests for additional information.
• Identify and communicate appropriately quantified risks and mitigations associated with regulatory strategies to cross‑functional team members.
• Lead development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide.
• Provide cross‑functional support for regulatory submissions and compliance, including approval of product labeling; review of clinical and human‑factor protocols; and writing/updating standard operating procedures, work instructions, and policies.

• Bachelor of Science required, preferably in a Scientific Field or Regulated Industry.
• Minimum 5 years experience in Regulatory or Quality (including experience with medical devices); experience in areas of product registration, compliance or quality systems.

• 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).
• Author and support 510(k), Tech File / STED File submissions as required.
• 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 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.
• Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
• Strong communication (written, oral) and project management skills.
• Ability to balance multiple tasks with attention to detail with limited supervision.
• Demonstrated global perspective, cross‑functional teamwork and partnership skills.
• Knowledge of US medical device regulations, 21 CFR 820 – Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.
• Limited travel required – 15%.

• Regulatory Affairs Certification (RAC)…