Medical Devices Project Manager

SGS is the world's leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.

Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.

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 Y+1 and Y+2.

Management of the client's certification process:

• Coordinate and manage the client's 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.

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 is an asset.
• Additional education or specialization related to regulatory affairs, medical devices, or management is an asset.