Vietnam Job Openings
Beckman Coulter Diagnostics
Regulatory Affairs Specialist
FULL TIME
October 17, 2024
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Regulatory Affairs Specialist for Beckman Coulter Diagnostics is responsible for managing all registration activities of all products distributed by Beckman Coulter Vietnam /Channel Partners in Vietnam and Cambodia, ensuring that all regulatory projects are completed within projected timelines.
This position is part of the Quality and Regulatory Affairs located in HCMC, Vietnam and will be working as onsite.
You will be a part of the SEA-North Quality and Regulatory Affairs team and report to the Senior Regulatory Affairs Specialist responsible for Vietnam and Cambodia. If you thrive in a collaborative and fast-paced environment and want to work to build a world-class Commercial organization—read on.
In this role, you will have the opportunity to:
- Ensure on-time product registrations (new, re-registration and variations) and handling all regulatory matters with Vietnam MOH.
- Assist and coordinate regulatory support for Vietnam channel partners.
- Manage the registration activities for Cambodia Channel Partner including the analyzing upcoming product variations and determine whether variation registration is required.
- Request/Review/check regulatory documents to ensure completeness and correct to attain right first-time submission.
- Effectively create and update registration record into Regulatory database.
- Other registration administrative support works as assigned by Senior RA Specialist.
The essential requirements of the job include: (NOTE For Hiring Manager: Please reference the 3-5-7 Model for Job Requirements found here )
- Education: Bachelor’s degree in Science/ Pharmacy/ Medical Engineering
- Experience: Minimum 03 years-experience in Regulatory environment for medical devices.
- Required skills: English Fluency, Strong computer application skills (Excel, Word, Power Point), strong knowledge of Vietnam/Cambodia regulations and ability to compliance, independent, proactive, careful, able to meet deadlines and deliver on critical plans, team work oriented, results and process driven.
It would be a plus if you also possess previous experience in:
- Worked in similar QRA position to in IVD industry.
- Familiar with local product registration procedures and requirements in Vietnam, Cambodia.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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