Senior Project Manager (IVD)

Our client is a growing diagnostics company improving the diagnosis and treatment of infections and contributing to the fight against resistance. A medical technology company based in Sweden, and part of a Global Group.

Their product enables rapid identification of both the bacteria and resistance, in record time. As part of team growth they are looking for a Senior Project Manager with a proven track record in product development across IVDs or Medical Device Technology.

Role:

The Senior Project Manager will play a key role in leading product development projects from early feasibility to global launch. Lead cross-functional project teams covering R&D, QARA and Operations, ensuring delivery on time, within budget and quality.

The Senior Project Manager will collaborate with internal stakeholders and external partners worldwide, ensuring project execution according to goals and compliance with regulatory requirements in EU, US, and Japan.

Responsibilities:

• Lead and manage IVD development projects (systems and assays) from concept to global commercialization
• Establish project plans, budgets, timelines and deliverables in line with Stage-Gate methodology
• Lead, Coordinate and facilitate cross-functional project teams
• Ensure compliance with regulatory requirements (IVDR, FDA, PMDA, etc.).
• Oversee quality and documentation processes according to ISO 13485 and ISO14971
• Report project status, risks, deviations and decisions to management and steering committees
• Contribute to continuous improvement of project models, processes, and tools for project management.

Requirements:

• Ideally Degree level education in Engineering, Life Sciences or equivalent practical expertise
• IVD/Medical device product development
• Track record of leading global product launches of diagnostic systems (hardware, software and assays)
• Understanding of regulatory requirements in EU (IVDR), and US (FDA 510k/de novo/PMA)
• Working under ISO 13485 (quality management systems)
• Knowledge of ISO 14971 (risk management for medical devices)
• Cross-functional project leadership in an international setting
• Project management methodologies (e.g., Stage-Gate, PMP, Prince2)
• Fluent in English
• Swedish desirable (not a deal breaker)