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 Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
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!
Job Summary
Completes and maintains regulatory approvals and clearances of assigned products.
Job Responsibilities
- Prepare and review product registration tasks covering the new product registration, progress reports, supplements, amendment, periodic reports and the renewal registration
- Support and coordinate with other functions to fulfill company’s regulatory tasks mandated by other existing local healthcare regulations, such as the completion of the device registration and tracking monthly reports, the device advertising application, the facilitation of device import exemption and other new regulatory requirement projects assigned by the authority bodies.
- Maintain good relationship with government authorities to keep up to date on regulations changes and trends; seek advice on interpretation of government guidelines and regulations to ensure compliance
- Support and carry out company internal regulatory, quality and compliance processes investigation, recall FDA reporting
- Track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in country/regions and provide regulatory updates to relevant stakeholders
- Obtain approvals from Ministry of Health/ Pricing Bureau/ other relevant authorities on the pricing and reimbursement levels
- Provide guidance and feedback to BUs on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects.
- Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
- Serve as regulatory representative to sales & marketing team, clinical team and regulatory agencies.
Preferred Requirements
- Bachelor's Degree in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry)
- At least 5 years related RA experience. Coursework, seminars, and/or other formal government and/or trade association training.
- Experience in preparing domestic and international product submissions is preferred.
Required Skills
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
- Excellent written and verbal communication skills including negotiating and relationship management skills.
- Full knowledge and understanding of country/regions regulations relevant to medical devices, Class II and/or Class III devices.
- Full knowledge and understanding of country/ regions regulatory requirements for new products or product changes.
- Ability to manage competing priorities in a fast paced environment
- Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness
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
TWN Taipei - Zhong Xiao E RdAdditional Locations
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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.