Staff Specialist - Global Labelling (m/f/d)

Job description

Purpose of Job:

Serves as the global subject matter expert and strategic leader for Product Use Information and labeling, driving compliance, governance, and transformation initiatives that support market access, business continuity, and the safe and effective use of medical devices throughout their lifecycle.

Acts as a strategic partner to global business functions and serves as a key liaison between cross-functional stakeholders, customers, and regulatory authorities. Drives Product Use Information objectives across Quality, Regulatory Affairs, Engineering, Manufacturing, Clinical Affairs, and other business functions to ensure consistent, compliant, and efficient labeling processes.

Provides leadership for complex, cross-functional labeling initiatives, overseeing all project phases from strategy and planning through execution and implementation. Defines project scope, priorities, resource requirements, and delivery plans to achieve business objectives while managing risks and ensuring compliance.

Leads initiatives that advance labeling excellence through process optimization, digital transformation, and the implementation of innovative technologies, enabling greater efficiency, scalability, and quality across the product portfolio.

Demonstrates a strong commitment to patient safety, product quality, and regulatory compliance, consistently upholding the organization's Quality Policy, ethical standards, and company values while fostering a culture of continuous improvement and operational excellence.

What You'll Do:

• Lead the development, maintenance, and lifecycle management of compliant product labeling in accordance with global regulatory requirements, international standards, and quality system requirements. Partner closely with cross-functional stakeholders, including Regulatory Affairs, Risk Management, Packaging, Medical/Clinical Affairs, and Quality, from concept through regulatory release.
• Represent the Labeling function during internal and external audits and inspections, ensuring regulatory compliance and effective resolution of audit observations.
• Drive investigation and resolution of non-conformances by identifying root causes, implementing corrective and preventive actions (CAPAs), and ensuring sustainable compliance improvements.
• Assess and interpret emerging regulations, standards, guidance documents, and quality agreements to define compliant implementation strategies for both legacy product portfolios and New Product Introduction (NPI) programs.
• Serve as Division Process Owner (DPO) for the Product Use Publications Quality Management System landscape, overseeing governance, periodic reviews, continuous improvement initiatives, and the development of best-practice guidance. Maintain ownership of DQP 16-001, the overarching procedure governing both Labels and Labeling processes.
• Develop and deliver training programs to ensure effective adoption of labeling processes, systems, and compliance requirements across the organization.
• Lead multiple concurrent, high-complexity labeling initiatives across new product development, sustaining engineering, and regulatory remediation programs, and lead the initiative for more project transparency within the team.
• Manage strategic cross-functional projects supporting medical device development, product lifecycle management, implementation of new regulatory requirements, and deployment of innovative technologies and systems that enhance labeling creation, review, compliance, and operational efficiency.
• Drive digital transformation and process modernization initiatives to improve scalability, automation, quality, and efficiency of global labeling operations.

What You'll Need:

• Experience in a highly regulated field, ideally in Regulatory Affairs or Labeling.
• Bachelor’s degree in a related field.
• 5 to 7 years’ work-related experience.
• Database affinity and XML language experience is a plus.
• Ability to produce results and successfully navigate change.
• Ability to creatively solve problems in a fast-paced environment.
• Ability to manage project timing.
• Independent workstyle with the capability to address risks and communicate challenges.
• Excellent problem-solving and analytical ability.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes.