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, they are 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.

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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• 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 factors 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…