Job Description

Post Market Quality Specialist reporting to Post Market Surveillance Manager has arisen in Kuala Lumpur, Malaysia. The Post Market Quality Specialist will work to ensure Cochlear meets the regulatory reporting requirements on post market surveillance in all jurisdictions where Cochlear products are marketed

Key Responsibilities

The Post Market Quality Specialist will be responsible for the generation and maintenance of post market surveillance reporting schedules.

In this role you will be responsible for:

• Collect and analyze product data and feedback to complete PMS (Post-market surveillance) / PMCF (post-market clinical follow-up) 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.
• Coordinate the submission of completed reports to regulatory agencies in the required format, including Periodic Safety Update Reports (PSUR\'s) in Eudamed.
• Collaborate with other business functions to obtain relevant information and fulfil PMS/PMCF reporting requirements to global standards.
• 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.

Key Requirements

• Minimum Degree in any relevant field
• At least 3 years of experience in complaints handling or post market surveillance
• Experience working in the Medical Device/ Pharmaceutical environment is highly desirable.
• Experience in data analysis and insight reporting will be an added advantage.
• Knowledge in medical terminology and EUMDR will be an added advantage.
• Advanced level of experience in MS Excel.
• Knowledge in Tableau and OBIEE - Oracle Reporting Tool is an added advantage but not a MUST.
• Ability to problem solve and think analytically with a continuous improvement mindset
• Attention to details and accuracy in data is highly critical for this role.
• Ability to comprehend written communication in English from staff where English is not their first language.
• Good English written and oral communication is a MUST for this role.

Advertised: 09 Jun 2023 Singapore Standard Time
Anticipated Application Closing: 29 Dec 2023 Singapore Standard Time

Cochlear