BD
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. 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 takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our medical devices—to look at the impossible and find transformative solutions. 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. 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 Regulatory Affairs and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing 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 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. Demonstrate 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 it fosters creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days of in-office presence per week is requested 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. Through the organization’s investment in BD University, you will continually level up your tech skills and expertise. To learn more about BD visit BD careers. 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. BD 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 . 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: BD offers a comprehensive compensation and benefits program. Salary ranges are provided as a general reference and may vary by location and role. The salary range information is provided for informational purposes only and is not a guarantee of compensation or employment status. Salary Range Information $130,400.00 - $215,200.00 USD Annual
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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. 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 takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our medical devices—to look at the impossible and find transformative solutions. 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. 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 Regulatory Affairs and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing 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 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. Demonstrate 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 it fosters creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days of in-office presence per week is requested 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. Through the organization’s investment in BD University, you will continually level up your tech skills and expertise. To learn more about BD visit BD careers. 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. BD 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 . 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: BD offers a comprehensive compensation and benefits program. Salary ranges are provided as a general reference and may vary by location and role. The salary range information is provided for informational purposes only and is not a guarantee of compensation or employment status. Salary Range Information $130,400.00 - $215,200.00 USD Annual
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