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Project manager

Project manager

EPM ScientificAntwerp, Flemish Region, Belgium
8 dagen geleden
Functieomschrijving

Freelance Project Manager - CE Certification | Medical Devices (Dialysis)

Location : Mechelen, Belgium

Duration : 6 to 12 months | 40 hours per week

Sector : Medical Devicesl

An opportunity has arisen for an experienced and strategically minded Freelance Project Manager to lead a highly complex and globally coordinated CE certification project for a technologically mature dialysis device. This role demands a high level of leadership, precision, and cross-cultural competence, as it spans stakeholders across Europe and Asia.

Key Responsibilities :

  • Oversee the preparation and finalisation of the Technical File, ensuring full compliance with Medical Device Regulation (MDR) and alignment with the defined regulatory strategy.
  • Act as the primary liaison between Research & Development and Regulatory Affairs-Quality Assurance (RA-QA) teams.
  • Coordinate seamlessly with internal teams in Belgium, corporate leadership and manufacturing partners in Japan, and stakeholders in Sweden.
  • Navigate cross-cultural and linguistic complexities with diplomacy and tact.
  • Deliver timely, structured, and concise project updates to senior management, ensuring project clarity at all times.

Required Competencies :

  • Demonstrated experience in leading product development and CE certification projects within the medical device sector.
  • Assertive and authoritative communication style, with the ability to command respect and drive alignment across geographically dispersed teams.
  • Strong facilitation skills with the confidence to bring stakeholders together, encourage collaborative discussion, and resolve ambiguity.
  • Proficient in structuring and delivering technical and regulatory content in accordance with MDR.
  • Prior experience with dialysis systems or Class IIb / III devices will be considered a significant advantage.
  • Fluency in English is essential; knowledge of Japanese, Dutch, or Swedish is advantageous.

    • What the Role Offers :

  • Engagement in a high-impact regulatory programme with direct implications for patient outcomes.
  • Autonomy and visibility within a global framework, collaborating with renowned international experts.
  • The opportunity to lead one of the most challenging yet rewarding regulatory initiatives currently underway in the medtech field.

    • Desired Skills and Experience

    Project Management experience

    Experience in Medical Devices

    MDR Knowledge

    Communicate and co-ordinate with R&D and QA / RA

    Coordinate with Japanese site

    Prepare technical files / dossier

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    Project Manager • Antwerp, Flemish Region, Belgium