Associate Manager - Regulatory Affairs & QA
Are you passionate about regulatory compliance? If so, this opportunity could be for you! Join us at B. Braun Indonesia, 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 a Associate Manager Regulatory Affair & QA at B. Braun you will play a vital role in organizing, monitoring, protecting and supporting the Medical Devices business by implementing the regulatory framework in the context of products registration (new registration, renewal, variation), promotion compliance, vigilance, quality assurance, CDAKB, CPAKB and others related B. Braun’s medical devices products
Your key responsibilities:
- Protect and support B. Braun’s business, innovation, and assets by implementing the regulatory framework and act as regulatory advisor in building and defending B. Braun
- Manage the appropriate regulatory submission and pre-market registration, while also interacting with health authorities to obtain and maintain products approvals
- Responsible for coordinating and preparing regulatory submission and strategies
- Support product development teams and other products development initiatives
- Provide regulatory guidance to department or development project team regarding design, development, evaluation
- Monitoring and reporting the effectiveness and any adverse effects or side effects of medical devices products on the market in the general population and in hospitals and research trials.
What you will bring to the team:
- Minimum a degree in Pharmacy
- Min 10 years of working experience in Medical Devices regulatory affair, CDAKB and CPAKB
- Fluent in English
What sets B. Braun apart?
B. Braun in Indonesia began in the 1980s through a local distributor, bringing with it over 30 years of experience in the Indonesian market. Committed to staying at the forefront, B. Braun Indonesia established a new pharmaceutical factory in 2017. This expansion led to the formation of two legal entities: PT B. Braun Medical Indonesia and PT B. Braun Pharmaceutical Indonesia. Today, we're proud to still be sharing the knowledge and expertise with the community to protect and improve the health of people in Indonesia and around the world.
What can we offer you?
- Hybrid work system
- Company devices provided.
- Education support & personal development
- Medical Insurance
- Annual Leave
- Regular team building and employee social gatherings.
What’s next?
Upon receiving your application, our dedicated Talent Acquisition team will meticulously review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. 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.
Profil perusahaan
B. Braun Melsungen AG is one of the world's leading providers and manufacturers of healthcare solutions today. Every service that B. Braun provides incorporates the entirety of our knowledge and skills, the company's deep understanding of users' needs, and more than 175 years of extensive expertise. With its constantly growing portfolio of effective medical care solutions, B. Braun makes a substantial contribution towards protecting and improving people's health. In total, the B. Braun product range comprises 5,000 different products, 95 percent of which are manufactured by the company. By offering supplementary services and consulting, B. Braun is a system supplier that develops the best solution for patients in close partnership with our customers, making a significant contribution to medical advancements. B.Braun Indonesia, a fast growing subsidiary of B. Braun Melsungen AG. We are seeking qualified individuals to join our team of highly trained and dedicated professionals who are committed to make B.Braun Indonesia a reliable partner to healthcare providers in Indonesia. It is our mission to help our medical professionals to provide affordable and safe healthcare for all Indonesians. Hence, if you are in line with our mission and take great pride in doing so, you are very welcome to join our team. For more information, please visit our official account: Facebook: https://www.facebook.com/BBraunIndonesia LinkedIn: https://www.linkedin.com/company/bbraun-group/ Website B. Braun Group: https://www.bbraun.com Website B. Braun Indonesia: https://bbraun.co.id All recruitment and selection processes at B. Braun Indonesia is held free of charge. Candidates will not be charged any cost.
101-1,000 employees
B. Braun Melsungen AG is one of the world's leading providers and manufacturers of healthcare solutions today. Every service that B. Braun provides incorporates the entirety of our knowledge and skills, the company's deep understanding of users' needs, and more than 175 years of extensive expertise. With its constantly growing portfolio of effective medical care solutions, B. Braun makes a substantial contribution towards protecting and improving people's health. In total, the B. Braun product range comprises 5,000 different products, 95 percent of which are manufactured by the company. By offering supplementary services and consulting, B. Braun is a system supplier that develops the best solution for patients in close partnership with our customers, making a significant contribution to medical advancements.