Job Description

The incumbent will be managing the team to ensure regulatory and quality assurance activities throughout the product lifecycle ranging from Pre-Market Medical Device Registration, Change Notification, Special Authorisations/Exemptions, and Post-Market Surveillance in collaboration with the relevant government bodies in Malaysia, Singapore and Indonesia.

• Consistently initiate, validate, review, plan, and strategise to ensure product compliance with all applicable statutory and regulatory requirements.
• Develop plans for and initiate process improvements, as well as the digitisation of RAQA work flows.
• Assume responsibility for Medical Device Establishment/Dealer Licensing with the relevant authorities.
• Oversee Pre-Market Medical Device Registration, Change Notification, Special Authorisations/Exemptions, and Post-Market Surveillance in collaboration with the relevant government bodies.
• Supervise and ensure compliance with other regulatory requirements set by relevant authorities and government bodies.
• Provide regulatory support to subsidiaries and associated companies located in Southeast Asia.
• Serve as the Management Representative (MR) for the implementation of ISO 9001, GDPMDS, and ISO 13485.
• Assist in liaising with Conformity Assessment Bodies/Certification Bodies and coordinate with respective process owners on audit and assessment-related matters.
• Coordinate and facilitate activities related to the preparation of Technical Files and CE Marking for medical devices manufactured.

Strong employee development and various training and advancement opportunities.|Attractive annual remuneration package.

• Bachelor\'s degree in Life sciences, Biomedical Science, Biotechnology, Nutrition or a related field accompanied by relevant experience in medical device.
• An established candidate with more than 5 years of experience in regulatory affairs and quality assurance in medical device or a related field.
• Great leadership and mentoring skills.
• Strong relationship and stakeholder management with government authorities, auditors and manufacturers.
• Possess working knowledge of ISO 9001 & GDPMDS, ISO 13485.
• Demonstrated ability to communicate, present, and influence effectively and convincingly at all levels of the organisation.

Our client is a leading medical device company operating in the heart of Malaysia. With a strong commitment to advancing healthcare through innovative solutions, the company has established itself as a key player in the region\'s biomedical industry. Their state-of-the-art facilities and cutting-edge research and development initiatives underscore their dedication to delivering high-quality products and services. They specialise in a wide range of biomedical solutions, including medical devices, diagnostic tools, and pharmaceuticals. What sets the company apart is its emphasis on sustainability and ethical practices, ensuring that its products not only benefit patients but also contribute positively to the environment.

• Cutting-Edge Innovation: At the forefront of the biomedical industry, consistently pioneering innovative solutions that impact healthcare on a global scale. Joining the team means being part of a dynamic environment where you can contribute to groundbreaking advancements in healthcare technology.
• Professional Growth: Places a strong emphasis on nurturing talent and providing opportunities for professional development. As an employee, you\'ll have access to ongoing training, mentorship programs, and the chance to work with experts in the field, ensuring your career continues to progress.
• Global Impact: The products and services have a significant impact on healthcare systems worldwide. By becoming part of the team, you\'ll play a crucial role in improving patient care and health outcomes on a global scale, making your work deeply meaningful and fulfilling.

Michael Page