BD
Overview
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 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 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 role involves developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance on international regulatory requirements, and overseeing worldwide submissions and negotiations for approval with agencies.
Responsibilities
Represent international regulatory affairs 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.
Represent MMS-Infusion for regulatory projects and lead 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 processes and implement 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
Experience creating dashboards and data analysis using tools like Power BI
Knowledge and Skills
Working knowledge of Regulatory Systems implementation
Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information
Digital literacy: MS Word, Excel, PowerPoint, Teams, Power BI
Effective communication of 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 conclusions verbally and in writing to varied audiences
Ability to solve practical problems based on a variety of concrete variables where standardization is limited
Work Arrangement and Policy
At BD, we prioritize on-site collaboration to foster creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days in-office per week is required to maintain our culture of excellence and ensure smooth operations. Remote or field-based positions will have different workplace arrangements indicated in the job posting.
For certain roles, employment is contingent upon proof of full vaccination against COVID-19. In some locations, testing may be available or required. BD’s Workplace Accommodations Policy provides accommodations pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions, and encourages you to bring your authentic self to work. We help each other be great, do what’s right, 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 and understand the human story that underpins everything we do. We welcome people with imagination and drive to help us reinvent the future of health. You’ll discover a culture where you can learn, grow, and thrive, and find satisfaction in contributing to a better world.
To learn more about BD, visit the BD Careers site at the following URL: https://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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Salary Range Information
Salary ranges have been implemented to reward associates fairly and competitively, with ranges varying by location. The salary range offered to a successful candidate is based on experience, education, skills, and the applicable pay system for the actual work location.
Salary Range Information: 124,700.00 USD - 205,800.00 USD annually
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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 role involves developing and executing strategies for worldwide governmental approval to introduce new products and maintain existing products to international geographies, providing guidance on international regulatory requirements, and overseeing worldwide submissions and negotiations for approval with agencies.
Responsibilities
Represent international regulatory affairs 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.
Represent MMS-Infusion for regulatory projects and lead 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 processes and implement 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
Experience creating dashboards and data analysis using tools like Power BI
Knowledge and Skills
Working knowledge of Regulatory Systems implementation
Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information
Digital literacy: MS Word, Excel, PowerPoint, Teams, Power BI
Effective communication of 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 conclusions verbally and in writing to varied audiences
Ability to solve practical problems based on a variety of concrete variables where standardization is limited
Work Arrangement and Policy
At BD, we prioritize on-site collaboration to foster creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days in-office per week is required to maintain our culture of excellence and ensure smooth operations. Remote or field-based positions will have different workplace arrangements indicated in the job posting.
For certain roles, employment is contingent upon proof of full vaccination against COVID-19. In some locations, testing may be available or required. BD’s Workplace Accommodations Policy provides accommodations pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions, and encourages you to bring your authentic self to work. We help each other be great, do what’s right, 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 and understand the human story that underpins everything we do. We welcome people with imagination and drive to help us reinvent the future of health. You’ll discover a culture where you can learn, grow, and thrive, and find satisfaction in contributing to a better world.
To learn more about BD, visit the BD Careers site at the following URL: https://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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Salary Range Information
Salary ranges have been implemented to reward associates fairly and competitively, with ranges varying by location. The salary range offered to a successful candidate is based on experience, education, skills, and the applicable pay system for the actual work location.
Salary Range Information: 124,700.00 USD - 205,800.00 USD annually
#J-18808-Ljbffr