Are you someone who excels in navigating medical device regulatory requirements, ensuring timely registrations, seamless life‑cycle maintenance, and effective collaboration with authorities, manufacturers, and internal stakeholders to keep products fully compliant and audit‑ready? If so, join us in the Regulatory Affairs team at B. Braun and make an impact that matters within a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!
As an Executive – Regulatory Affairs (Medical Devices) with us in B. Braun, you will play a vital role in managing product registrations, maintaining regulatory compliance throughout the device life cycle, liaising with regulatory authorities and global/regional teams, and supporting audit readiness to ensure our medical devices reach and remain in the market safely and effectively. This is a 1-year contract position with possibility of a conversion, depending on the business needs and performances, though it's not guaranteed.
Your key responsibilities:
- Carry out medical device product registrations in accordance with country-specific business requirements and global/hub guidelines.
- Manage life‑cycle maintenance for medical devices, including renewals, change notifications, and applications for Special Access.
- Maintain up‑to‑date registration status to ensure full compliance with government regulations and company requirements.
- Build and maintain positive relationships with the Medical Device Authority and other relevant bodies.
- Liaise daily with manufacturers, regional hubs, and local stakeholders such as Sales & Marketing and Supply Chain.
- Maintain and report medical device product registration data accurately and timely.
- Support GDPMD audit activities and coordination.
What you will bring to the team:
- Bachelor's degree/ Diploma in Science or related discipline, specifically within Biology, Physics, Engineering, Healthsciences, etc.
- Min 2 - 3 years of experience with medical devices product registration within Malaysia.
- Experience and knowledge in Malaysia product registration regulations and policies.
What sets B. Braun apart?
Incorporated in 1980, B. Braun Medical Supplies Sdn Bhd is well placed as one of the leading medical suppliers in Malaysia. We work closely in partnership with hospitals and healthcare institutions for best patient outcomes. Our proven track record as a major hospital supplier of medical devices, equipment and pharmaceuticals paves the way for market leadership.
Our team’s extensive networking within the industry, together with B. Braun’s evolving and progressive product quality help us in our mission to protect and improve people’s health in Malaysia and around the world.
What can we offer you?
- Sports club
- Annual leave
- Medical insurance
- Employee incentive scheme
- Retirement benefit scheme
- Long service award
- Employee referral program
- Education assistance program
- BMS Business School for learning & development
What’s next?
Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. We ask you to conduct two interviews, one in person and one remotely. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!
We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.
To find out more about our commitment to diversity click here
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To find out more about B. Braun Malaysia click here