As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

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.

Job Description

• Work collaboratively with project teams to conduct updates to regulatory Technical Documentation
• Responsible for existing technical documentation in accordance with the requirements of IVDR (EU) 2017/746. Report on status of files, including identification and remediation of gaps
• Conduct regulatory assessments for changes to products and processes
• Develop and update internal procedures and processes
• Develop and update files to fulfill UKCA regulations
• Provide support for CE marking activities including preparation and submission of product technical files, product labeling reviews, and support to international registrations and product release to market activities.
• Perform other Regulatory Affairs duties and assignments as required

Education and Experience:

• B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.). RAC Certification a plus.
• 1-2 years of experience in medical devices required (must have experience in one of the following areas in medical devices: Regulatory Affairs, Quality or R&D).
• Knowledge and experience with regulatory requirements for medical devices (CE mark technical files and design dossiers)
• Flow cytometer experience a plus.

Knowledge and Skills

• Must be able to handle multiple tasks with attention to detail and limited supervision.
• Excellent oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
• Excellent organization & prioritization skills, especially ability to facilitate and document
• Ability to identify areas of concern in complex projects and manage changes.
• Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork
• Computer literacy (Information Systems, Microsoft Word / Excel / PowerPoint)
• Comprehensive knowledge of regulatory requirements for in vitro diagnostic devices.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://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, 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

MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift