Senior Manager, Technical Service – Compliance

This is a fully remote position, open to applicants in Denmark.

📋 Description

• Direct the global service compliance strategy and execution, ensuring alignment with regulatory and quality standards.

• Take ownership of the Service Quality Management System (QMS), promoting consistent implementation across various regions.

• Oversee CAPA processes, field actions, and compliance investigations in accordance with regulatory standards.

• Ensure readiness for audits and inspections; lead both internal and external quality system audits.

• Manage and enhance the Quality Control Test (QCT) process, particularly focusing on QCT1, to ensure timely and compliant triage.

• Create and present quality insights, fostering data-driven decision-making and ongoing improvement.

• Act as the primary compliance point of contact across Service, R&D, Regulatory Affairs, and Post-Market Surveillance to ensure comprehensive issue resolution.

⛳️ Requirements

• Master’s degree in Regulatory Affairs, Engineering, STEM, or Commercial fields.

• A minimum of 10 years of progressive experience in quality, compliance, or service operations within the medical device industry or a related regulated healthcare sector.

• Extensive knowledge of ISO 13485, 21 CFR Part 820, MDR, and other global regulatory frameworks.

• Proven experience in leading CAPA systems, audit processes, field action coordination, and compliance investigations in a regulated environment.

• Practical experience with Data Analytics and Dashboards using PowerBI and advanced Excel.

• Demonstrated leadership skills with strong stakeholder communication and the capacity to drive change management initiatives.

• Background in designing and implementing scalable compliance processes that have positively impacted audit outcomes and customer satisfaction metrics.

• Willingness to travel up to 20%, including international travel as necessary.

🏝️ Benefits

• Health care program

• Paid time off