Post Market Quality Specialist

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives Cochlear is hiring for an enthusiastic Post Market Quality Specialist who will ensure Cochlear meets the regulatory reporting requirements on post market surveillance in all jurisdictions where Cochlear products are marketed The Ideal candidate will follow relevant quality procedures to deliver quality products and services and identify and support the implementation of continuous improvement. As well as contribute ideas on systems and process methods to improve deliverables. This role also carries the responsibility for the generation and maintenance of post market surveillance reporting schedules This is a full-time permanent role based in our Kuala Lumpur office, hybrid work options are available Accountabilities Post Market Surveillance Reporting

• Collect and Analyse product data and feedback to complete PMS/PMCF reports according to plans, and where required by regulatory business needs
• Check and correct errors and problems that may not be immediately evident in the data, systems, or processes
• Collaborate with other business functions to obtain relevant information and fulfil PMS/PMCF reporting requirements to global standards
• Coordinate the submission of completed reports to regulatory agencies in the required format

PMS Reporting Schedule Maintenance and Communication

• Coordinate with relevant functions to create and maintain PMS/PMCF reporting schedules that provide good alignment among different projects and jurisdiction requirements, ensure reporting efficiency and on-time delivery
• Support and maintain internal communications, intranet page or other platform/s, ensuring current and accurate information on product reports are readily available to the business
• Communicate product monitoring status updates as required

Continuous Improvement

• Identify process improvement opportunities, proactively engage in and work collaboratively with stakeholders on its development and implementation
• Identify and develop enhancements to systems that increase efficiencies through automation

Key Incumbent Requirements

• Strong numerical and analytical skills with previous experience in data analytics and insights
• Strong attention to detail with proven track record of delivering high quality reports and insights
• Proactive and demonstrates curiosity and creativity to uncover trends and opportunities in data, translating this into meaningful insights and operational excellence
• Excellent written and verbal communication skills including experience with presenting data, insights to key stakeholders
• Advanced MS Excel skills and experience with business intelligence tools
• Experience in the medical device industry (Desirable)
• Experience dealing with notified bodies and regulatory authorities (Desirable)
• Understanding of clinical and/or medical terminology (Desirable)
• Experience with business intelligence and visualisation tools such as Tableau, OBIEE (Desirable)

Language Requirements

• English - Fluent
• Mandarin - Advanced

Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below #CochlearCareers