Post Market Quality Specialist

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; Híbrido; MYR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Cochlear Malaysia Sdn Bhd is hiring a Post Market Quality Specialist to ensure regulatory PMS/PMCF reporting across jurisdictions. This full-time role in Kuala Lumpur offers hybrid work options and requires a degree with 3+ years in data management or post-market surveillance.

Responsibilities include collecting data, producing PMS/PMCF reports, coordinating regulatory submissions, and driving data-driven improvements with cross-functional teams.

Formación

• Minimum degree in any relevant field.
• At least 3 years of experience in data management, business intelligence analysis, or post-market surveillance.
• Strong numerical and analytical skills with experience in data analysis, insight reporting, and delivering high-quality reports.
• Proactive mindset with curiosity to identify trends and opportunities in data, translating findings into actionable insights.
• Advanced proficiency in MS Excel and familiarity with BI visualization tools such as Tableau and OBIEE.
• Excellent written and verbal communication skills; strong English, plus Mandarin to support China stakeholders.
• Attention to detail and accuracy in handling data.
• Experience in the medical device industry and regulatory authorities is advantageous.

Responsabilidades

• Collect and Analyse product data and feedback to complete PMS/PMCF reports according to plans and regulatory needs.
• Coordinate the submission of completed reports to regulatory agencies in the required format.
• Collaborate with cross-functional teams to gather information and fulfill PMS/PMCF reporting requirements to global standards.
• Maintain PMS/PMCF reporting schedules, ensuring alignment across projects and jurisdictions.
• Support internal communications and ensure current information on product reports is accessible.
• Identify process improvements and drive automation opportunities with stakeholders.

Conocimientos

Data management

BI analysis

Data analysis

MS Excel

Tableau

OBIEE

English language

Mandarin language

Communication skills

Regulatory knowledge

Educación

Bachelor's degree

Herramientas

Tableau

OBIEE

Descripción del empleo

Cochlear's mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry's best clinical, research and support networks. That's why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life's opportunities.

The Opportunity

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 position based at our Kuala Lumpur office, with hybrid work options available.

Accountabilities

• 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
• 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
• Minimum Degree in any relevant field.
• At least 3 years of experience in data management, business intelligence analysis, or post-market surveillance.
• Strong numerical and analytical skills, with proven experience in data analysis, insight reporting, and delivering high-quality reports.
• Proactive mindset demonstrating curiosity and creativity to identify trends and opportunities in data, translating findings into meaningful insights that drive operational excellence.
• Advanced proficiency in MS Excel and experience with business intelligence and visualization tools such as Tableau and OBIEE (Oracle Business Intelligence Enterprise Edition) is preferred.
• Excellent written and verbal communication skills, with the ability to present data and insights to key stakeholders. Strong command of English, including the ability to understand and interpret communications from colleagues for whom English is a second language. Proficiency in both spoken and written Mandarin is required to support effective communication and collaboration with stakeholders in China.
• High attention to detail and accuracy in handling data is critical for this role.
• Ability to think analytically and problem-solve with a continuous improvement mindset.
• Experience in the medical device industry, familiarity with clinical and/or medical terminology, and experience dealing with notified bodies and regulatory authorities are advantageous but not mandatory.

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.