The Project Manager is a key role in the MDR project. The Project Manager has the overall responsibility to ensure that the project is performed according to the Certification Agreement and the quality management system requirements, ensure a good internal communication with all resources and units involved in the project to have a smooth and efficient execution of the project, and to ensure a good cooperation and communication with the customer.

Responsibilities:

• Ensures that the audit package is upload in the Production system.
• Recommend certification based on the QMS audit and prepares recommendation for certification, including the draft certificate (assisted by the assessor for MDR certificate), and sends audit and assessment documentation and reports to technical review.
• Communicates with Planner and/or person in charge of Sales if any changes in Certification Proposal or agreement must be initiated.
• Communicates with Certification Manager, MDSAP Technical Manager for MDSAP Processes, and/or Global Clinical Affairs Manager if issues related to safety and performance of the medical device is identified during the audit/assessment, and the need of suspension/withdrawal of the certificate must be considered.
• Coordinate and lead planning sessions for project development and execution
• Manage staffing and other resources needs to maximize potential for successful execution of projects
• Coordinate within medical services delivery by working closely with the Global Certification Unit(GCU) and other units/managers
• Define project objectives and scope, identifying involvement of internal and external stakeholders
• Conduct risk analysis to reduce unforeseen obstacles and costs
• Create detailed schedule, project parameters, and budget expectations
• Create a complete project plan with timelines from technical file submission to certificate issuance
• Conduct periodic scope, schedule, and cost reviews using industry best practices, to identify needed adjustments
• Measure project performance and progress throughout campaign execution
• Manage client and other stakeholder expectations to maintain productive and engaged relationships
• Ensure professional and responsive customer support, leading to high customer satisfaction and maintaining a strong market reputation
• Document project activities, obstacles, costs, and results
• Assist the planning & scheduling in accurate scheduling and optimal resource utilization
• Delegate project activities and duties in accordance with team members’ strengths and experience
• Provide summarized project plan documentation to departmental managers, clients, and other stakeholders as needed
• Act as single point contact for the customer for all project related activities
• Engage in continual learning to remain abreast of industry best practices, new technologies, and emerging standards
• Collaborate with and lead teams to deliver results on schedule and within budget limits
• Maintain medical services to meet the requirements from Notified Bodies(NB) and accreditation standards
• Cooperate with the finance team for forecast preparation, analysis, and support in invoicing processes
• Assist in handling complaint management to promptly address issues and uphold service quality
• Execute other role duties as assigned

• Flexible work schedule with hybrid/selective working opportunities for better work-life balance
• Generous paid leaves (annual paid leave, special paid leave)
• Pension and insurance policies (corporate life insurance, local group insurance, travel insurance, retirement pension)
• Additional benefits (meal allowance, transportation allowance, holiday bonus, tuition assistance for children, annual medical check-up, long service awards)
• Competitive salary along with profit share

Required:

• Minimum of 10 years of relevant experience in a similar role, with a preference for experience within the medical industry
• University degree or equivalent qualification; technical background is a plus
• Fluent in English is a must
• Demonstrated experience in managing complex projects involving multiple stakeholders
• Strong client communication skills and proven ability to build and maintain excellent client relationships
• Excellent organizational, coordination, and project management abilities

Preferred:

• Self-motivated with a positive and proactive attitude.