Senior Manager, Technical Service & Compliance (Remote)

Job summary

The Senior Manager, Technical Service & Compliance is responsible for leading the global service compliance strategy, ensuring adherence to regulatory, quality, and internal standards across service operations. This role focuses on governance, audit readiness, and continuous improvement to mitigate risk and enhance operational excellence.

Qualifications

• Master's degree in Regulatory, Engineering, STEM, or Commercial fields.
• 10 years of progressive experience in quality, compliance, or service operations within the medical device industry or related regulated healthcare sector.
• Deep understanding of ISO 13485, 21 CFR Part 820, MDR, and other global regulatory frameworks.

Responsibilities

• Lead global service compliance strategy and execution, ensuring alignment with regulatory and quality standards.
• Own and maintain the Service Quality Management System (QMS), driving consistent implementation across regions.
• Manage CAPA processes, field actions, and compliance investigations in line with regulatory requirements.
• Ensure audit and inspection readiness; lead internal and external quality system audits.
• Own and improve the Quality Control Testing (QCT) process, ensuring timely and compliant triage.
• Develop and deliver quality insights, driving data-based decision-making and continuous improvement.
• Serve as the key compliance interface across Service, R&D, Regulatory Affairs, and Post-Market Surveillance to ensure end-to-end issue resolution.

Skills

Travel

• Hands-on experience in Data Analytics and Dashboards through PowerBI and advanced Excel.
• Proven leadership capability with strong stakeholder communication and the ability to drive change management initiatives.
• Experience in designing and implementing scalable compliance processes with demonstrated impact on audit outcomes and customer satisfaction metrics.
• Ability to travel up to 20%, including international travel as required.