Post Market Quality Specialist

Change peoples 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 peoples lives.

Cochlears 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 industrys best clinical research and support networks. Thats 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 lifes 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

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

• 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 experience presenting data and insights to key stakeholders. Strong command of English including the ability to comprehend written communication from staff for whom English is a second language.
• 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 Cochlears 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.

Cochlear Malaysia provides shared services to support Cochlears 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.

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