Regulatory Compliance Manager

The Regulatory Compliance Manager will oversee and ensure adherence to regulatory standards within our organization. The ideal candidate will possess a strong background in quality management and compliance, with a focus on FDA regulations, CGMP, and various quality systems. This role is critical in maintaining the integrity of our operations and ensuring that all processes meet industry standards.

• →Develop, implement, and maintain compliance programs that align with regulatory requirements.
• →Conduct quality audits to assess adherence to internal policies and external regulations.
• →Monitor compliance with FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• →Collaborate with cross-functional teams to ensure effective quality management practices are in place.
• →Lead training initiatives to educate staff on compliance protocols and quality assurance measures.
• →Manage documentation related to quality systems and compliance activities.
• →Identify areas for improvement within the compliance framework and propose actionable solutions.
• →Prepare reports on compliance status and present findings to senior management.

• Bachelor’s degree in a related field.
• 5 years experience in regulatory compliance and quality assurance testing and management.
• Strong understanding of quality audits and quality management principles.
• In-depth knowledge of FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• Proven experience in project management with the ability to lead initiatives effectively.
• Excellent analytical skills with attention to detail for identifying compliance issues.
• Strong communication skills for effective collaboration across departments.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Proficiency in developing quality systems that support organizational goals.