Project manager

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.