Regulatory Affairs & Quality Management System Executive

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 Regulatory Affairs & Quality Management System Executive to be responsible for In-vitro & In-vivo medical devices related regulatory submissions and implement.


Your mission and responsibilities:

1. Product Registration

  • You will identify, analyze and implement country specific regulatory requirements related to In-vitro & In-vivo medical devices

  • You will plan and prepare In-vitro & In-vivo medical devices related submissions according to regulatory requirements
  • You will submit required documentation/ information to local authorities such as Medical Device Authority, MoH and SIRIM QAS Sdn Bhd

  • You will perform training within the organization in country specific regulatory requirements

  • You will perform review of promotional material for regulatory compliance according to country specific requirements

  • You may represent the company in industry associations

  • You will report to local authorities in a timely manner on post market surveillance activities such as Adverse Event Reporting & Field Safety Corrective Action (FSCA)

2. Quality Management System

  • You will maintain certification to ISO 9001, other national regulatory standard/ guidelines such as Good Distribution Practice Medical Devices (GDPMD) and Atomic Energy Licensing Board (AELB) and any other standards which might deem necessary

  • You will ensures effective cooperation with both internal and external stakeholders to ensure effective implementation of the organization's Quality and EHS Management system

  • You will be involved in analyzing process workflow and propose improvements to management

  • You will promote quality awareness throughout the organization


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


Your qualifications and experiences:

  • You hold a successfully completed Degree in natural sciences i.e. Biomedical, Pharmaceutical Studies or Medical Engineering or equivalent

  • You have at least 2 years of working experience in the field of regulatory affairs or equivalent

  • You have experience in registration of wireless telecommunication components/ devices (e.g. Bluetooth, ultra-wide band, wireless footswitches) with SIRIM QAS would be an added advantage


Your personality and skills:

  • You are meticulous and detail orientated

  • You are able to work independently

  • You are proficient in MS Office

  • You are proficient in English and Bahasa Melayu both written and spoken


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: 191654

Organization: Siemens Healthineers

Company: Siemens Healthcare Sdn. Bhd.

Experience Level: Early Professional

Job Type: Full-time

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