Quality & Regulatory Affairs Executive (Contract)

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 opportunity to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

Then come in and join our Malaysia SH team as **Quality & Regulatory Affairs Executive (Contract)** to support both Laboratory Diagnostics (In-Vitro) & Imaging (In-Vivo) medical devices related regulatory submissions & implementations of quality management systems.

***Your task and responsibilities**:

- 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 (MDA), MoH and SIRIM QAS Sdn Bhd
- 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)
- Experience in registration of wireless telecommunication components/ devices (e.g. Bluetooth, ultra-wide band, wireless footswitches) with SIRIM QAS would be an added advantage
- 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 maintain and ensure effective cooperation with both internal and external stakeholders to ensure effective implementation of the organization's Quality and EHS Management system
- You will involve in analyzing process workflow and propose improvements to management
- You will promote quality awareness throughout the organization

**Your qualifications and experiences**:

- You have University degree in natural sciences (for example biomedical, pharmaceutical studies or medical engineering) or equivalent
- You have at least two (2) years of working experience in regulatory affairs for medical devices and Good Distribution Practice Medical Devices (GDPMD)

**Your personality and skills**:

- You are proficient in computer skills, including Microsoft Office suite (Microsoft Word, PowerPoint, Outlook and Excel).
- You are meticulous and detail oriented
- You have a good command of written and spoken English and Bahasa Melayu.
- You are able to communicate effectively with internal and external customers in all mediums of communication.
- You are self-directed and able to work with mínimal supervision

**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.

**Organization**: Siemens Healthineers

**Company**: Siemens Healthcare Sdn. Bhd.

**Experience Level**: Mid-level Professional

**Full / Part time**: Full-time