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Quality & Regulatory Affairs Manager

Job Description

Do you want to help shape the future of healthcare? Our name, Siemens Healthineers (SHS), was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

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. Sounds interesting?

Then come in and join our Thailand team as Quality & Regulatory Affairs Manager to lead our Quality team in Thailand and ensure full compliance with Thai FDA regulation.

Your mission and responsibilities:

  • You are responsible to register and maintain product licenses of assigned in full compliance with Thai FDA regulation.
  • You are responsible for reviewing and approving advertising and promotional items to ensure regulatory compliance.
  • You will handle post-marketing activities and yearly reporting requirements of company and product licenses.
  • You will communicate updated registration status and advertising approval to internal relevant parties.
  • You are responsible for handling of post-marketing requirements for IVDs and MDs and ensuring the requirement are met. This includes Adverse Event reporting and Field Safety Corrective Actions to ensure compliance with global and local requirements.
  • You are the point-of-contact with government agency such as Thai FDA, Embassy, Ministries of Commerce and Ministries Foreign Affairs for legalized or register products.
  • You are responsible for submission documents and get approval import permit at Atom of Peace.
  • You will update registration information and registration status in company database.
  • You are responsible to implement and maintain a Quality Management System in compliance with Healthineers Quality and EHS Requirements and any local regulations.
  • You will also conduct audits on suppliers and business partners where needed besides audits on Thailand internal Quality Management System.
  • You are responsible to keep abreast of all the new MD/IVD and EHS regulations and requirements especially that which impact the business directly and communicate these requirements to Regional Office and Business Lines.

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/

Your qualifications and experiences:

  • You hold a successfully completed Degree in any science discipline, such as Biomedical, Pharmaceutical Studies or Medical Engineering or equivalent.
  • You have at least 5 years of working experience in the field of regulatory affairs or equivalent, preferably in the Medical Devices/Food Science.

Your personality and skills:

  • You are meticulous and detail orientated.
  • You are able to work independently and manage the Quality team under you.
  • You are proficient in MS Office.
  • You are proficient in English and Thai (both written and spoken).

Our global team:

Siemens Healthineers is a leading global medical technology company. 66,000 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.

Our culture:

Our culture embraces 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 invite you to take on new challenges, test your ideas, and celebrate success.

Check our Career Site at https://www.healthcare.siemens.com/careers

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here (https://talent.siemens.com/stayconnected) to get started.

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: Siemens Healthcare Limited

Experience Level: Experienced Professional

Job Type: Full-time

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