Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Responsibilities
Job Description Summary
Job Description
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’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.
Why Join Us?
A career at BD means learning and working 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.
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.
Become a maker of possible with us!
Key responsibilities:
- Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.
- Collect and organize labeling related documentation for core team member review.
- Perform gap analysis to support labeling projects.
- Review label specifications for adherence to labeling procedure requirements.
- Compile and categorize cross-functional feedback as an output to labeling review requests.
- Assist in regulatory activities related to US and OUS labeling remediation.
- Review protocols, reports, and journal articles to ensure collection of appropriate data to support promotional materials.
- Help draft and route standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Remain current on standards and regulations affecting advertising, promotion, and labeling and communicate the impact cross-functionally.
- Perform other duties and assignments as required.
- Support activities and attend team meetings outside of standard workings hours.
Professional Skills & Key Competencies
- Excellent verbal and written communication skills.
- Demonstrated ability to analyze, interpret, and review scientific, technical, and regulatory literature and documents.
- Excellent attention to details.
- Flexible and adaptable to fulfill business priorities.
- Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).
- Manages time efficiently.
Minimum Qualifications:
- Bachelor’s degree in Life Sciences or Engineering.
- One (1) to three (3) years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry.
- Excellent interpersonal, communication and analytical skills.
Desired/Additional Skills & Knowledge:
- Familiarity and background with advertising, promotion, and labeling in the medical device industry.
Certifications
- RAPS RAC a plus.
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
To learn more about BD visit: https://bd.com/careers
Primary Work Location
MYS Kuala Lumpur - Jalan KerinchiAdditional Locations
IND Bengaluru - Technology CampusWork Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.