Quality & Regulatory 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 in and join our global team as Quality & Regulatory Officer to understand the requirements and prepares product related regulatory submissions.


Your mission and responsibilities:

Regulatory

  • You will be responsible for timely management and coordination of Singapore product registration especially for in-vitro products i.e. new product and product amendments. This would include product grouping and risk classification

  • You will need to be familiar with risk classification and IVD product grouping

  • You will ensure that FSCA (Field Safety Corrective Actions) is completed in timely manner for ASEAN IVDs

  • You will ensure close out of IVD FSCA with HSA

  • You will be responsible for application of CRM (Clinical Research Materials)

Quality

  • You will be responsible as an auditor for business partners or distributors

  • You will be responsible as an editor/ reviewer for some SOPs

  • You will be responsible for cross countries projects collaboration


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

 

Your qualifications and experiences:

  • You have at least 3 years of relevant experience preferably in regulatory affairs in in-vitro diagnostics

  • You hold a successfully completed Diploma or Degree in any science discipline

  • A qualified auditor would be handy although not necessary


Your personality and skills:

  • You possess some knowledge in the post-market requirements including FSCA. Preferably also some knowledge in GDPMDS (Good Distribution Practice for Medical Devices) requirements including managing some processes pertaining to this area

  • You are able to work independently and meticulously with minimum supervision


Being part of our team:


Siemens Healthineers is a leading global medical technology company. More than 48,000 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.


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


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.


Job ID: 187802

Organization: Siemens Healthineers

Company: Siemens Healthcare Pte Ltd

Experience Level: Early Professional

Job Type: Full-time

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