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 arethe 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 amakerof possiblewith us.

Responsibilities:

• 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 standards 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 with limited 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 interfacing with FDA personnel during 510(k) review and meetings with the Agency.

Knowledge, Skills, and Abilities:

• Comprehensive 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.
• Demonstrated 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 prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Click on Apply if this sounds like you!

Why Join Us?

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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.

To learn more about BD visithttps://bd.com/careers

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.

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA CA - San Diego Bldg A&B, USA CA - San Diego TC Bldg C&D

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$130,400.00 - $215,200.00 USD Annual