Regulatory Affairs for Medical Device (Contract position)

Regulatory Affairs for Medical Device (Contract position)

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 to grow both personally and professionally. Sound interesting? Then come in and join Malaysia team as Regulatory Affairs (For Medical Device) – On Contract.

Your tasks and responsibilities:

• You will be responsible for Pre-market and Post-market Surveillance activities for In-Vitro & In-Vivo medical devices with national competent authorities such as Medical Device Authority (MDA) and Malaysian Communications and Multimedia Commission.
• You will support to maintain quality management system based on International / national regulatory standard/guidelines such as Good Distribution Practice Medical Devices (GDPMD) and ISO 9001.

Pre-market Medical Device Registration

• Identify, analyze, and implement country specific regulatory requirements related to In-Vitro & In-Vivo medical devices.
• Plan and prepare In-Vitro & In-Vivo medical devices related submissions according to regulatory requirements.
• Submit required documentation/information to local authorities such as Medical Device Authority, MoH and Malaysian Communications and Multimedia Commission.
• Experience in registration of wireless telecommunication components/devices (e.g. Bluetooth, ultra-wide band, wireless footswitches) with SIRIM QAS would be an added advantage.

Post-market Surveillance and Vigilance

Report to local authorities in a timely manner on post market surveillance activities such as Adverse Event Reporting, Field Safety Corrective Action (FSCA) and Medical Device Recall.

Quality Management System

• Maintain certification to ISO 9001, other national regulatory standard/guidelines such as Good Distribution Practice Medical Devices (GDPMD) and any other standards which might deem necessary.
• Ensure effective cooperation with both internal and external stakeholders to ensure effective implementation of the organization's Quality and EHS Management system.
• Involve in analyzing process workflow and propose improvements to management.
• Promote quality awareness throughout the organization.

Your qualifications and experience:

• University degree in natural sciences (for example biomedical, pharmaceutical studies or medical engineering) or equivalent.
• At least 2-3 years of working experience in regulatory affairs for medical devices and Good Distribution Practice Medical Devices (GDPMD) or equivalent industry such as pharmaceutical industry.

Your attributes and skills:

• You have a learning attitude.
• Fluent in English & BM both written & spoken.
• Well experienced in MS Office.

Our global team:

We are a team of 68,000 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.

Our culture:

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.

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.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job’s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.