Senior Regulatory and Quality Officer

Job Description

Do you want to contribute to the future of healthcare? As Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer.

We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone in order to grow both personally and professionally. Sound interesting?

Then come and join our Indonesian team as Senior Regulatory and Quality Officer to ensure adherence to Quality management / assurance related processes and procedures, and oversees related operational and/or supportive activities. 

Your mission and responsibilities:

  • You will be responsible for quality management system in Indonesia, shall be made to the Siemens Healthineers Regulation and dynamic local regulation.
  • You will be responsible to monitor and support regulatory process for DI/AT/US for new and amendment submission
  • You will be responsible to monitor and support DI/AT/US FSCA handling (incl verification and translation)
  • You will be responsible to monitor and coordinate the validity of NERA import license (Kuota Bapeten) and X-ray compliance test
  • You will be responsible to monitor and submit any update changes for SDAK and AKL (distribution license and product license) to MoH
  • You will be responsible to monitor, submit, and support regulatory process of license requirement from Menkominfo

To find out more about the specific business, have a look at

Your qualifications and experiences:

  • You have experience with the regulations concerning medical devices

  • You hold a successfully completed Degree in Pharmacy, Biomedical Engineering, or equivalent

Your personality and skills:

  • You are self-driven, motivated and have a positive work attitude

  • You have excellent communication skills to manage organization

  • You are proficient in English both written and spoken

Being part of our team:

Siemens Healthineers is a leading global medical technology company. More than 53,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Your cultural fit:

Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we want you to seek, implement and celebrate your best ideas.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

Organization: Siemens Healthineers

Company: PT Siemens Healthineers Indonesia

Experience Level: Mid-level Professional

Job Type: Full-time

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