Associate Manager

1 day ago

Jakarta, Jakarta, Indonesia B. Braun Full time

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 & QAat 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.

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