Becton Dickinson
Staff Regulatory Affairs Specialist (Hybrid)
Becton Dickinson, San Diego, California, United States, 92101
Maker 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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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. This position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is responsible for developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions and negotiating their approval with the agencies. Responsibilities Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Represents MMS-Infusion for regulatory projects and leads the efforts for successful implementation. Identify and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to stakeholders. Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Prepare global strategies for changes to commercialized products. Work cross-functionally and lead cross-functional teams to implement global updates. Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors informed about potential impact. Identify ways to improve the efficiency of current work process and execute them. Performs other duties and assignments as required. Qualifications Education Bachelor's degree in biology, engineering, or other science related discipline Advanced degree (e.g. MS, PhD) preferred Certifications RAPS RAC RCC certifications preferred Experience Minimum of 5 years of directly related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field Experience in Regulatory and Quality Information Management systems such as SAP, RIM, Veeva, Sharepoint or related systems Working experience on creating dashboards and data analysis using tools like power BI. Knowledge and Skills Working knowledge Regulatory Systems implementation Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information Digital literacy MS Word, Excel, PowerPoint, Teams, Power BI Effectively communicate information to peers and all levels of management. Ability to translate regulations and guidelines into terms that other functions can understand and apply Ability to define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists 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. 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. 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. 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.
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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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. This position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is responsible for developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions and negotiating their approval with the agencies. Responsibilities Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Represents MMS-Infusion for regulatory projects and leads the efforts for successful implementation. Identify and communicate appropriately quantified risks and mitigation strategies associated with international regulatory strategies to stakeholders. Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Prepare global strategies for changes to commercialized products. Work cross-functionally and lead cross-functional teams to implement global updates. Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors informed about potential impact. Identify ways to improve the efficiency of current work process and execute them. Performs other duties and assignments as required. Qualifications Education Bachelor's degree in biology, engineering, or other science related discipline Advanced degree (e.g. MS, PhD) preferred Certifications RAPS RAC RCC certifications preferred Experience Minimum of 5 years of directly related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field Experience in Regulatory and Quality Information Management systems such as SAP, RIM, Veeva, Sharepoint or related systems Working experience on creating dashboards and data analysis using tools like power BI. Knowledge and Skills Working knowledge Regulatory Systems implementation Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information Digital literacy MS Word, Excel, PowerPoint, Teams, Power BI Effectively communicate information to peers and all levels of management. Ability to translate regulations and guidelines into terms that other functions can understand and apply Ability to define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists 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. 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. 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. 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.