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 companyxe2x80x99s name is dedicated to our employees. Itxe2x80x99s their pioneering spirit, blended with our long history of engineering in the ever-evolving halthcare 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) xe2x80x93 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 etc.
• 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 Vigilancexc2xb7 Report to local authorities in a timely manner on post market surveillance activities such as Adverse Event Reportin, 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.
• Ensures 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.

To find out more about the specific business, have a look atYour 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 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 whatxe2x80x99s possible in healthcare to help improve peoplexe2x80x99s 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 whatxe2x80x99s possible, to improve peoplexe2x80x99s 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.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. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click to get started.To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobxe2x80x99s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

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