Regulatory Affairs Specialist

Job Overview

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.

• 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.

• 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.

• 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.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

Salary Range Information: $ - $ USD Annual

Primary

Work Location:

USA CA - San Diego. Additional Locations: USA CA - San Diego Bldg A&B, USA NJ - Franklin Lakes.

Work Shift:

Primary Work Shift unspecified.

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.