Regulatory Affairs Professional

1 day ago

กรงเทพมหานคร, Thailand Siemens Healthineers Full time

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come and join our
**Thailand** team as a
**Regulatory Affairs Professional** to
**assist in obtaining and maintaining government approval for medical devices, reagents, and related materials.**

**Your tasks and responsibilities**:

- You will be responsible for register and maintain product licenses of assigned in full compliance with Thai FDA regulation.
- You will be reviewing and approving advertising and promotional items to ensure regulatory compliance.
- You will handling post-marketing activities and yearly reporting requirements of company and product licenses.
- You can communicate updated registration status and advertising approval to internal relevant parties.
- You can contact government agency such as Thai FDA, Embassy, Ministries of Commerce and Ministries Foreign Affairs for legalized or register products.
- You will be responsible for submission documents and get approval import permit at Atom of Peace.
- You will update registration information and registration status in company database.

**Your qualifications and experience**:

- You hold a successfully completed Degree in any science discipline, such as Biomedical, Pharmaceutical Studies or Medical Engineering or equivalent.
- You have at least 2-3 years of working experience in the field of regulatory affairs or equivalent, preferably in the Medical Devices/Food Science.
- You are proficient in MS Office.
- You have experiences in transacting with NBTC for WiFi/Bluetooth connectivity devices would be an advantage.

**Your attributes and skills**:

- You have Strong communication skills in English and Thai, both verbal and written.
- You are a self-starter with the ability to work independently and proactively.
- You are meticulous and detail orientated.
- You are able to work independently.

**Our global team:
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

**Our culture**:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

**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.

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