Head of Global Compliance

K Line Europe

1.Global Compliance Strategy: Develop and execute the overall, risk-based global compliance strategy, advising the executive team and Board of Directors.

2.Regulatory Oversight: Direct all global regulatory submission activities (e.g., 510(k), CE Marking) and manage all internal and external regulatory audits (e.g., FDA, Notified Body).

3.QMS Leadership: Ensure the global Quality Management System (QMS) meets all international standards and drive its continuous improvement.

4.Risk & CAPA Management: Implement a robust global compliance risk management framework and oversee the Corrective and Preventive Action (CAPA) system, including product recalls and non-conformities.

5.Global Training: Establish and lead a worldwide compliance training program for all employees to maintain a strong ethical and compliant corporate culture.

Required International Compliance Standards

The successful candidate must Certified Auditor and possess expert, demonstrable knowledge and experience in key global standards including ISO 13485, ISO 14971, and MDSAP, as well as major regional regulations such as US FDA 21 CFR Part 820 (QSR), EU MDR/IVDR requirements for custom-made devices (Annex XIII), and key Asian regulatory requirements (e.g., Japan PMD Act, China NMPA)

Qualifications & Experience

Experience: A minimum of 10 years of professional experience is required, including at least 4 years in a senior executive capacity with worldwide compliance oversight.

Leadership: Proven ability to lead and mentor global, cross-functional teams and advise the Board of Directors on complex compliance matters.

Skills: Exceptional strategic thinking, communication, and decision-making skills. Must be fluent in English.

Preferred Certifications

Certified Compliance & Ethics Professional (CCEP) or equivalent.

Regulatory Affairs Certification (RAC).

Lead Auditor Certification (e.g., ISO 13485).