Medical Devices Project Manager

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November 25

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SGS

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Compliance • SaaS • Sustainability

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

10,000+ employees

Founded 1878

📋 Compliance

☁️ SaaS

📋 Description

• Act as the local representative for SGS Notified Body (NB) for the Medical Device Technical Office in the assigned region. • Coordinate and monitor certification activities in compliance with the 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 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 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 to identify and plan annual business needs, including forecasts for Y+1 and Y+2.

🎯 Requirements

• Bachelor's degree in a scientific or technical discipline • Project Management certification (e.g. PMP, PRINCE2) is an asset • Knowledge of QMS/Medical Device approval processes is desirable • Experience in the medical device industry or familiarity with conformity-assessment processes is advantageous • Previous project management experience, preferably managing multiple projects in parallel • Demonstrated ability to coordinate complex projects involving multiple stakeholders • Experience working within structured, procedure-driven environments • Fluent in English and Portuguese or Spanish (written and spoken) • Excellent communication, negotiation, and stakeholder management skills • Analytical mindset with strong IT literacy (Microsoft Office, Teams, Project Management tool) • Ability to develop good working relationships and adapt to change

🏖️ Benefits

• Work remotely • Proactive follow-up throughout the certification process • Professional development opportunities