STAFF REGULATORY COMPLIANCE SPECIALIST

STAFF REGULATORY COMPLIANCE SPECIALIST (Ethicon Inc., Ciudad Juarez, Chihuahua, Mexico)

The Regulatory Compliance Specialist, under the supervision of the Regulatory Compliance Manager, is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.

You will be responsible for

• Support external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, room/back room arrangements, identifying/preparing SMEs, etc.
• Support external audits/inspections of the site e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, or JJRC/ERC.
• Assess the risk and applicability of external audit/inspection observations from other J&J facilities to determine impact to the site.
• Support mock external audits/inspections as part of External Audit...