Regulatory Affairs Specialist
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This job is a Regulatory Affairs Specialist role at BD Biosciences focusing on medical devices. You might like this job because it involves maintaining CE IVD dossiers and regulatory assessments for product changes. Requirements include a BS degree in health or life sciences and experience in medical devices.
Undisclosed
Kuala Lumpur, Kuala Lumpur
Full-Time
few days ago
Job Description
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.
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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!
The Regulatory Affairs Specialist will be working in the BD Biosciences Unit on IVD devices with a focus on meeting sustaining IVDR requirements with guidance from the Regulatory Affairs Manager. This position requires an understanding of the current IVDR regulatory framework and processes to maintain CE IVD dossiers and sustain registered devices. Additionally, the position will include regulatory assessments for product changes, internal procedures updates, registration file support, and other related activities (e.g., UKCA transition).
Job Responsibilities:
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.
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
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Primary Work Location
MYS Kuala Lumpur - Jalan KerinchiAdditional Locations
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Additional Info
Company Activity
Last active - few hours ago
Experience Level
0 - 10 Years of Experience
Job Specialisation
Doctor / Health Specialist, HR Operations (Payroll, Admin, Office Management), Talent Acquisition / Recruitment
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