Regulatory Compliance Manager

Title: Regulatory Compliance Manager (WORD version )

Industry: Medical Instruments

Function: Administration

Value-Added Results Performance Standards

More effective complaint handling process • Average time to closure reduced from 7 months to 4—5.5 months.
• Create a mechanism to allow major product issues to surface while complying with regulatory requirements.

• Revise BOSP-001 to reflect changes in the complaint process.

Organizational development • Create job descriptions for every position.
• Develop succession plan for every employee in the department and each job family progression.

• Identify training needs for each employee.

• Provide resource and knowledge base for GMP interpretation and compliance.

GMP training • Provide a basic level of GMP knowledge in the DDC verified with pre-post testing.

Value-Added Results	Performance Standards
More effective complaint handling process	• Average time to closure reduced from 7 months to 4—5.5 months. • Create a mechanism to allow major product issues to surface while complying with regulatory requirements. • Revise BOSP-001 to reflect changes in the complaint process.
Organizational development	• Create job descriptions for every position. • Develop succession plan for every employee in the department and each job family progression. • Identify training needs for each employee. • Provide resource and knowledge base for GMP interpretation and compliance.
GMP training	• Provide a basic level of GMP knowledge in the DDC verified with pre-post testing.