Senior Manager IVDR

Senior Manager IVDR (Consultant – 13–15 months)

Location: Brussels, Belgium (Hybrid – minimum 3 days/week on-site)

Contract Type: Full-time consultancy

Duration: 13–15 months, starting end of 2025

About the Role

We are seeking a highly experienced Senior Manager IVDR (Consultant) for a 13–15 month assignment. This role comes at a pivotal time, with revisions to the IVD and MDR regulations expected in 2025/2026.

The successful candidate will play a key role in shaping the regulatory landscape for diagnostic healthcare in Europe through strategy development, technical expertise, and stakeholder advocacy.

Key Responsibilities

• Build strategy and advocacy for the IVD sector, ensuring industry perspectives are well represented.
• Provide technical regulatory support to address complex regulatory challenges.
• Coordinate the IVD Regulatory Affairs Committee (RAC) and relevant Working Groups (e.g., Innovation, Clinical Evidence, Class D IVD, Software).
• Manage and support a small team, with potential supervisory responsibilities.

Requirements

• Extensive regulatory affairs experience, ideally with strong knowledge of the IVD sector.
• Proven ability to engage stakeholders at EU level, including political discussions on technical topics.
• Strong communication, coordination, and advocacy skills (written and spoken).
• Experience working within associations or demonstrated ability to build internal consensus.
• Able to work both independently and collaboratively in team settings.
• Flexibility to attend in-person meetings and travel as required.

Interested? Send your CV to m.spinetta@panda-int.com