Sr Regulatory Affairs Specialist, Dx Malaysia
7 days ago
In our line of work, life isnât a given - itâs the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world weâre located. Creating impactful innovations like ours, doesnât happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs biggest health challenges.
The RA Specialist for Radiometer is responsible for interpreting MDA regulations apply to Radiometer and Shared OPCOs products and advising on impact of regulations, devising strategies for compliance, and liaison with internal and external stakeholders to achieve the licenses, certificates, and other approvals which are in compliance with the medical device regulations and/or other regulations in Malaysia.
This position is part of the Global Regulatory Affairs department located in Brønshøj, Denmark and will be Hybrid position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
You will be a part of the Global Regulatory Affairs team and report to the Senior Director Regulatory Affairs responsible for the team that supports new product development RA and ensuring the market access is maintained in the worldwide markets.
If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work to build a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.
In this role, you will have the opportunity to:
- Initiate local registrations/renewal/license amendment planning and process with close collaboration with cross-functional teams to support the achievement of business objectives in Malaysia.
- Draft Malaysia specific CSDT, conduct product and technical file reviews and create high quality of submissions for speedy approvals.
- Ensure regulatory compliance to maintain market approvals.
- Monitor the evolving Regulatory requirements and trends, participate to influence, and drive system and process improvement projects, including but not limited to new regulatory requirements and processes, ensuing appropriate collaboration with stakeholders.
- Support post market surveillance activities as required.
It would be a plus if you also possess previous experience in:
- Bachelorâs degree in technical or scientific related field preferred with at least 3 yearsâ experience in Regulatory Affairs within In vitro Diagnostic Devices or medical devices
- Strong regulatory knowledge of MDA requirements for product registration.
- Strong written and communication skills in English and Malay, and comfortable working in a dynamic multi-functional environment.
Hybrid
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs 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. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. 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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