Medical Devices Project Manager

Main Purpose of Role

• The Project Manager (PM) is responsible for coordinating and monitoring the full certification cycle for medical devices under SGS NB 1639. Acting as the main link between clients Delivering Offices auditors and global teams the PM ensures projects are delivered efficiently in compliance with SGS procedures and regulatory requirements.

Key Accountabilities

• Act as the local representative for SGS Notified Body (NB) 1639 for the Medical Device Technical Liaison Office (MDTLO) in the assigned region.
• Coordinate and monitor certification activities in compliance with SGS NB 1639 procedures and controlled timelines.
• Maintain an overview of ongoing certification processes and customer contract history acting as the main contact person between clients auditors Product Assessors clinical and final reviewers and global teams responsible for certification review technical management and certification decision.
• Prepare and monitor the Certification Project Plan (IVDR only) and follow up on Change Notifications to ensure they progress according to the defined process.
• Review and monitor Incident Notifications submitted by customers collect additional information when necessary and provide written justification for proposed decisions by the Notified or Certification Body.
• Track and report MDTLO KPIs and Delivering Office (DO) relationships (monthly reports).
• Monitor and report PM KPIs and collaborate with other SGS NB 1639 Project Managers to ensure effective global PM and resource planning.
• Support Quality or Regulatory teams with the investigation and resolution of complaints and non-conformities as required.
• Collaborate with MDTLO partners to identify and plan annual business needs including forecasts for Y1 and Y2.

Management of the clients certification process:

• Coordinate and manage the clients certification cycle covering MDR IVDR combined standards with ISO 13485 UKCA and MDSAP from contract initiation to certification cycle completion.
• Ensure alignment with SGS NB 1639 procedures and timelines across all stages (on-site audits unannounced audits technical documentation assessments final review).
• Participate in project kick-off meetings with the customer and Delivering Office after contract signature to align project scope and timelines.
• Monitor audit scheduling progress in CertIQ and ensure is updated accordingly.
• Verify that Technical Documentations are uploaded in SharePoint and that all related information (status links and dates) is properly completed in .
• Monitor and follow up on Change Notifications to ensure they progress in accordance with defined processes and timelines supporting overall compliance.
• Coordinate Technical Documentation Assessments between the client Product Assessors and the Central Pool.
• Generate and review weekly CertIQ reports to track Technical Documentation Assessment progress and update .
• Follow up on concessions and non-conformance reports (NCRs) by reviewing reports and coordinating with Delivering Offices to ensure timely resolution.
• Support the Final Review process by completing form 5108 following up on open queries and ensuring all reviewer feedback is addressed.
• Ensure all certification steps are completed and compliant before the certification decision is issued.
• Collaborate with local Delivering Offices (DOs) Global Business Services (GBS) and SGS NB 1639 teams to ensure continuous progress of the certification contract

Project management coordination:

• Co-develop and maintain tools for tracking project progress and KPIs.
• Ensure all project data and KPIs are accurately updated in in line with global reporting requirements.
• Support data integrity by ensuring that client information is correctly entered by the D.O and maintained in CertIQ.
• Generate and analyse CertIQ reports to support Delivering Offices (DOs) and the PM team in operational and strategic decision-making.
• Monitor KPI performance provide feedback and improvement suggestions and support the implementation of corrective actions.
• Collaborate and share best practices with other SGS NB 1639 Project Managers to enhance global consistency and coordination.

Business development tracking

• Collect and consolidate MDTLO business development plans assess their impact on competence and resource requirements and provide feedback to both MDTLO and SGS NB 1639 management.

Client relationship:

• Ensure all communication with customers is timely and professional.
• Review and action all customer requests appropriately.
• Follow timelines for contract execution and maintain proactive follow-up throughout the certification process.

Qualifications :

Skills & Knowledge

• Fluent in English (written and spoken)
• Excellent communication negotiation and stakeholder management skills
• Analytical mindset with the ability to interpret KPIs
• Effective interpersonal skills able to develop good working relationships with both colleagues and clients
• Willingness to learn and adapt to change committed to continuous personal and professional development
• Able to follow procedures rules and best practices applied by SGS Belgium NV (NB 1639) and SGS
• Strong IT literacy (Microsoft Office Teams Project Management Tool(s) or equivalent).
• Knowledge of QMS/Medical Device approval processes is an asset.
• Understanding of applicable medical device regulations and guidance (EU MDR/IVDR IMDRF MDCG CS etc.) is an asset.
   

Experience

Essential

• Previous project management experience preferably managing multiple projects in parallel.
• Demonstrated ability to coordinate complex projects involving multiple stakeholders and technical disciplines.
• Experience working within structured procedure-driven environments (e.g. certification quality management or regulatory industries)

Desirable

• Experience in the medical device in-vitro diagnostic or healthcare industry.
• Familiarity with conformity-assessment or certification processes (MDR IVDR MDSAP UKCA).
• Experience developing or improving project management tools and processes.

Qualifications

• Bachelor-level education in a scientific or technical discipline (e.g. Engineering Biology Chemistry Biomedical Sciences).
• Certificate in Project Management (e.g. PMP PRINCE2 or equivalent) is an asset.
• Training or coursework in Quality Management Systems (ISO 9001 or ISO 13485) is an asset.
• Additional education or specialization related to regulatory affairs medical devices or management is an asset.
   

Remote Work :

Yes

Employment Type :

Full-time