Director Global Quality, Regulatory & Clinical (QRC) (m/f/d)

Revvity, Inc.; Lübeck; On-site; EUR 180,000 - 230,000; Full time

Job summary

Euroimmun – a Revvity company – is seeking a global QRC leader who blends deep IVD product understanding with Regulatory and Clinical judgement to integrate Quality, Regulatory Affairs and Clinical Affairs in a global matrix.

The role goes beyond a classic Head of Quality, delivering IVDR transition, FDA pathways, and digitalised QRC processes to improve Time-to-Market.

Qualifications

• University degree in natural sciences, medicine, biotechnology or related field.
• PhD or equivalent advanced qualification preferred.
• Minimum seven years of senior IVD experience spanning EU IVDR and FDA.
• Experience with 510(k) strategy/clearance and De Novo authorisation; direct FDA interaction.
• Deep competence in IVD Clinical/Performance Evidence, including study design and statistics.
• Strong Design Quality, NPI and risk-management capability; ISO 13485/MDSAP knowledge.
• Proven leadership in a global, multi‑country matrix environment.
• Excellent English; very good German for Lübeck-based leadership.

Responsibilities

• Own global strategic direction of Quality, Regulatory & Clinical across the full product lifecycle.
• Lead global QRC strategy and governance for Quality NPI, Operations, QMS, PMS, Regulatory, Clinical and Scientific Affairs.
• Define regulatory strategies for FDA and CE-IVDR; engage on critical dossiers and submission readiness.
• Own Clinical/Performance Evidence strategy, including study design and interpretation.
• Establish harmonised, risk-based quality and governance structures; prioritise CAPA/remediation.
• Lead the global QRC organisation; develop leaders; build a matrix operating model.
• Partner with BUs, R&D, Global Ops, Commercial and Digital Solutions to enable market access.
• Represent QRC in interactions with FDA, Notified Bodies, authorities, auditors and partners.

Education

University degree in natural sciences/medicine/biotechnology

PhD or equivalent advanced qualification

Job description

Euroimmun – a Revvity company - is seeking a global QRC leader who combines deep IVD product understanding with hands‑on Regulatory and Clinical judgement and the leadership breadth to integrate Quality, Regulatory Affairs and Clinical Affairs in a global matrix.

The mandate goes well beyond a classical Head of Quality or corporate compliance role: the successful leader will complete the IVDR transition, establish repeatable and successful FDA pathways, strengthen product‑near Regulatory and Clinical leadership, develop leaders and simplify, digitalise and automate regulated QRC processes while improving Time-to-Market.

Your new responsibilities

• Own the global strategic direction and continued development of Quality, Regulatory & Clinical across the full product lifecycle. Ensure that QRC influence development, production and business decisions early.
• Lead global QRC strategy and governance for Quality NPI, Quality Operations, QMS & PMS, Regulatory Affairs, Clinical Operations and Scientific Affairs, including Design/Product Quality, Supplier Quality, Vigilance, Clinical Data/Biostatistics and inspection readiness.
• Define and challenge global regulatory strategies, with particular focus on FDA pathways in the United States and CE-IVDR in Europe; personally engage at expert level on critical dossiers, authority questions and submission readiness.
• Own Clinical/Performance Evidence strategy, including study design, Performance Evaluation, statistical interpretation and claims, and ensure evidence decisions are tightly linked to product and portfolio logic.
• Establish globally harmonised, risk‑based quality and governance structures; use quality, compliance and portfolio metrics to prioritise CAPA/remediation, compliance escalation and resource decisions.
• Lead the global QRC organisation, develop its leaders, strengthen succession and capability pipelines and shape an effective operating model for a global matrix.
• Partner with Business Units, R&D, Global Operations, Global Commercial and Automation & Digital Solutions to support market access, product development, lifecycle management and faster critical paths from Design Freeze or market‑entry decision to commercialisation.
• Represent the global QRC function with confidence and authority in interactions with FDA, Notified Bodies, Competent Authorities, auditors, external partners, key customers and scientific networks.

What makes this position special

• The role will shape an integrated global QRC organisation and create the conditions for close collaboration across Quality, Regulatory, Clinical, Operations, Commercial and R&D while strengthening integration into Revvity governance.
• The organisation is moving from a structure developed over more than three decades into a more integrated global matrix. The leader must simplify without losing technical depth, product proximity or speed.
• The position combines broad decision rights with hands‑on subject‑matter depth.

What sets you apart

• A university degree in natural sciences, medicine, biotechnology or a comparable technical/scientific discipline is required. A PhD or equivalent advanced qualification is clearly preferred, but not a knockout.
• At least seven years of combined senior IVD experience spanning both EU‑IVD/IVDR and FDA
• Personal responsibility for successful 510(k) strategy/clearance and De Novo strategy/authorisation, plus direct FDA Pre-Sub/Q-Sub interaction and substantive IVDR portfolio conversion responsibility.
• Deep own competence in IVD Clinical/Performance Evidence, including study design, Performance Evaluation, statistics and claims; management oversight alone is insufficient.
• Strong IVD assay‑development understanding from concept through Design Freeze, with substantive immunoassay and/or serology experience and the ability to derive Regulatory and Clinical strategy from product and portfolio logic.
• Proven leadership of leaders, responsibility for at least two of Quality, Regulatory and Clinical, and international/multi‑country leadership in a matrix environment.
• Experience transforming regulated expert organisations through process simplification, Lean Governance, digitalisation/automation and measurable improvements in critical paths or Time‑to‑Market.
• Strong Design Quality / Quality NPI and product/process risk‑management capability. Knowledge of ISO 13485 and MDSAP is expected in the wider global quality context.
• Clear, confident and audience‑appropriate communication. Excellent English is essential; very good German is required for effective leadership and stakeholder interaction in the Lübeck‑based organisation.