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Are you passionate about Regulatory Affairs and driven to make an impact in the pharmaceutical industry? This RA Manager will work closely with the CEO and key stakeholders in Southeast Asia to ensure successful regulatory objectives. Your expertise will be crucial in overseeing regulatory projects.
The incumbent is tasked with supporting the Account Manager in delivering comprehensive pre-sales and post-sales assistance for the Microbiology sector in hospitals. This position involved collaborating with the team to proved instrumental application training, troubleshoot issues and offer all technical support to the customers and distributors.
The incumbent will oversee the nursing services and implement initiatives aimed at enhancing patient quality outcomes. This involves supervising clinical risk management and assessment programs, as well as supporting clinical teammates to ensure the delivery of safe and effective clinical care with optimal performance in medical procedures.
My client is an established Medical Device MNC and currently looking for a Market Access Lead to support their strategy and market development in Malaysia with the knowledge of the health care system and local trends.
The Nursing Country Lead will coordinate various strategies and complex programs, ensuring adequate support and education for the country's medical teams. The incumbent will also collaborate with the country management team to achieve clinical goals and receive regular updates on the team's activities. Also, the responsibilities will include root cause analysis process to address non-conformity and conducting monthly review of adverse occurrences.
The incumbent will be responsible for managing and overseeing clinical trials, ensuring compliance with protocols, regulations and ethical standards while collaborating with functional teams to execute clinical studies, oversee data collection and reporting through site visits. You will also be able to contribute to groundbreaking research initiatives and advance medical discoveries in a dynamic environment.
The incumbent will oversee the execution of clinical initiatives, ranging from quality assurance, training clinical nurses, audits and supporting the clinical education of various dialysis centres within the designated area. There will be collaboration with the clinical team and operations team to ensure the delivery of high-quality nephrology services.
The Medical Reviewer, with a medical doctor background will be in a dynamic role that involves conducting medical case assessment expertise within the APAC region. This is done to assist the Global Consumer Safety Department in conveying the findings and conclusions regarding global adverse events or product and health inquiries. The incumbent will be the subject matter expert in ensuring data trend reviews and medical recommendations to stakeholders.
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.
The incumbent should possess substantial commercial expertise in selling consumable medical devices, to excel in formulating and implementing sales strategies, overseeing marketing initiatives, and propelling revenue expansion. You will have the capacity to cultivate robust partnerships not only within internal teams but also with medical practitioners and stakeholders nationally. Furthermore, you will monitor sales forecast to achieve the business goals.
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