Lead Labelling Specialist

About the role

As a Lead Labelling Specialist you will be the technical authority for solving the most complex, ambiguous and high‑impact medical device labelling challenges across the product lifecycle. You will partner with cross‑functional teams to translate regulatory, product and market inputs into clear, compliant labelling that supports product safety and quality.

Key responsibilities

• Take hands‑on ownership of the most complex labelling problems and lead their resolution.
• Shape end‑to‑end labelling system architecture, including workflows, decision points and escalation pathways.
• Provide technical leadership on interpretation and application of labelling regulations, standards and guidance.
• Lead development and implementation of improved processes, templates, structured‑content approaches and tooling such as ELS/CCMS.
• Act as senior escalation point for complex labelling matters, coordinating stakeholders and applying risk‑based judgement.
• Partner with regulatory, quality, engineering, operations and UX leaders on process design and change impact.

Required profile

• Deep technical knowledge of medical device labelling regulations, standards and guidance.
• Bachelor’s degree in a relevant science, engineering, regulatory or technical discipline, or equivalent experience.
• 8+ years of experience in labelling, regulatory, quality or technical operations within complex, cross‑functional environments.
• Proven ability to solve complex, ambiguous labelling or regulatory problems and lead process or system improvements.
• Strong stakeholder management, influencing and communication skills, with ability to build credibility with senior leaders.

Required skills

• Experience with enterprise labelling and structured‑content systems such as ELS/CCMS.
• Ability to apply risk‑based judgement to regulatory requirements and evidence.