QARA Labelling Contract- MDR IVD- EU US UDI
This is a genuinely high-impact contract sitting within a global life sciences organisation undergoing significant transformation across its Quality and Regulatory landscape.You'll step into a programme-critical role, taking ownership of global labelling initiatives that span multiple regions, product lines, and manufacturing sites. The work is highly visible, strategically important, and sits right at the intersection of Quality, Regulatory, Supply Chain, and commercial delivery.
The role
You'll act as the central programme lead for labelling across the business.Working across Regulatory Affairs, QA, Packaging, Manufacturing, Artwork, and Commercial teams, your focus will be on ensuring labelling is not only compliant, but consistent and scalable globally.
What that looks like in practice:
- Owning end-to-end delivery of global labelling programmes (incl. remediation, harmonisation, and compliance uplift)
- Driving execution of artwork updates, IFUs, UDI implementation, and market-specific labelling requirements
- Leading programme governance - timelines, budgets, risk tracking, stakeholder alignment
- Aligning senior stakeholders across regions to deliver consistent labelling strategies
- Acting as the point of escalation for labelling-related risks, compliance gaps, and operational challenges
- Supporting audit and inspection readiness, particularly around labelling controls and documentation
- Improving how labelling is managed across the business - systems, processes, and ways of working
What they're looking for
This role suits someone who sits comfortably between programme leadership, regulatory understanding, and operational delivery.You'll likely bring:
- Strong exposure to labelling, artwork life cycle, or product information management
- Solid understanding of global regulatory requirements (FDA, EU MDR/IVDR, GMP, UDI etc.)
- Experience working across multiple functions - particularly Regulatory, QA, and manufacturing
- Confidence influencing senior stakeholders and driving alignment across regions
- Experience working with labelling or artwork systems
- Exposure to transformation or large-scale change programmes
- Exposure to a complex, global operating model
- A role with genuine ownership and visibility
- The initial 9-month contract with strong forward planning in place - highly likely to extend into a longer-term programme (~18-24 months).
If you're interested, apply now with your latest CV or get in touch directly for more details.If this role isn't right, but you're open to new opportunities in Quality or Regulatory, feel free to reach out for a confidential discussion.
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