Job Description Summary

The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on compliance projects, product engineering, new product development, and other regulatory-related development initiatives and maintenance activities.

Job Description

We are the makers of possible 

 

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 MedTech 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. 

Job Description:

• Coordinate, prepare, and complete premarket applications to the US FDA including Premarket Notification [510(k)] and Pre/Q-Sub submissions in a timely manner. Act as liaison with FDA regarding product submissions.

• Assess US regulatory requirements for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.

• Support technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.).

• Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing useful regulatory guidance throughout the product development cycle prior to regulatory submission.

• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to collaborators.

• Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.

• Lead regulatory efforts required to align with new regulations and requirements.

• Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance.

• Prepare, submit, and maintain global regulatory submissions and registrations.

• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

• Coordinate and respond to customer requests for product information.

• May represent BD in relevant external trade organizations and regulatory standard's development to support BD’s continuous product development and compliance efforts.

• Working knowledge of regulations for sterile class II devices, preferably related to IV infusion disposables.

• Identify current work process inefficiencies and implement improvements.

• Execute the above tasks without supervision.

Qualifications:

• Bachelor’s degree, preferably in a life sciences field. Advanced degree preferred.

• Minimum of 5 years Regulatory Affairs experience in medical devices, preferably sterile single-use disposable products.

• Proven ability to resolve problems and make appropriate regulatory decisions.

• Demonstrated success in the preparation and completion of 510(k) submissions.

• Experience collaborating with FDA personnel during 510(k) review and meetings with the Agency.

Knowledge, Skills, and Abilities:

• Extensive knowledge of US medical device regulations including 21 CFR 820 - Quality System Regulation / design

• controls, consensus standards, and FDA guidance documents.

• Strong critical thinking, communication, and project management skills.

• Proven global perspective, customer focus, cross-functional collaboration, and teamwork skills.

• Current knowledge of European quality system standards and requirements under MDD and MDR.

• Ability to function in a matrix organization.

• Proficient in using Microsoft Outlook, Word, Excel, PowerPoint, and Adobe.

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing r