BD Nogales Norte
Staff Regulatory Affairs Specialist
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BD Nogales Norte 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: 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 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, enables us to 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 input from supporting functions (R&D, Quality, Manufacturing, etc.). Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting 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 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 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. Note: The company indicates on-site collaboration is prioritized. For most roles, a minimum of 4 days in-office per week is expected to maintain culture and operations. Remote or field-based positions will be indicated in the posting. Some locations may require proof of full vaccination against COVID-19 and may include testing; accommodations will be considered per applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and promotes learning and growth. You’ll work with leaders and colleagues who are passionate about fostering an inclusive, growth-centered culture. BD University supports ongoing skill development. To learn more about BD, visit
bd.com/careers . 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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, or veteran status, and other legally-protected characteristics.
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at
BD Nogales Norte 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: 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 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, enables us to 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 input from supporting functions (R&D, Quality, Manufacturing, etc.). Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting 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 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 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. Note: The company indicates on-site collaboration is prioritized. For most roles, a minimum of 4 days in-office per week is expected to maintain culture and operations. Remote or field-based positions will be indicated in the posting. Some locations may require proof of full vaccination against COVID-19 and may include testing; accommodations will be considered per applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and promotes learning and growth. You’ll work with leaders and colleagues who are passionate about fostering an inclusive, growth-centered culture. BD University supports ongoing skill development. To learn more about BD, visit
bd.com/careers . 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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, or veteran status, and other legally-protected characteristics.
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