Regulatory Compliance Manager

Descripción del Empleo:
• Apply existing regulations to ensure compliance with existing EMEA/Canadian regulations
• Have full responsibility for audit programmes in accordance with quality compliance team
• Participate in global quality compliance teams and support implementation of harmonized procedures.
• Ensure adherence to the company quality audit schedule in international sites.
• Report to regional and international management on the status of all audits.
• Interface with company employees, dealers and distributors regarding quality compliance activities.
• Interact with regulatory agencies in regards to audits and responses until closure.
Requisitos:
Bachelor’s degree in physical/biological sciences or engineering preferred
8 years experiences in medical devices or pharmaceutical
Expertise in standards and regulations for medical devices as ISO 13485, IEC 62304, IEC 62366, ISO 14971, CFR Part 820
QMS and Audit Expertise
Good distribution Practice