Regulatory Compliance:
- Monitor Regulatory Changes and stay updated on the latest regulatory changes and industry standards, including FDA, ISO, and other relevant regulations.
- Conduct internal audits to assess compliance with regulatory requirements, internal policies, and standard operating procedures (SOPs).
- Develop and implement comprehensive compliance programs, including code of conduct, anti-bribery and corruption policies, and data privacy policies.
- Oversee the regulatory approval process for new products, devices, and clinical trials.
- Respond to inquiries from regulatory agencies in a timely and accurate manner.
Quality Assurance:
- Implement and maintain quality management systems, such as ISO 13485.
- Ensure the quality of products and services through rigorous quality control processes.
- Monitor and manage supplier quality performance and compliance.
- Develop and implement procedures for managing product recalls.
Data Privacy and Security:
- Ensure compliance with data privacy regulations, such as HIPAA and GDPR.
- Implement data security measures to protect sensitive patient information.
- Develop and implement a data breach response plan.
Risk Management
- Conduct Risk Assessment, Identify and assess potential compliance risks.
- Develop and implement strategies to mitigate compliance risks.
- Monitor and review risk assessments and mitigation plans.
Training and Education
- Develop and deliver compliance training programs for employees at all levels.
- Promote a culture of compliance and ethical behavior
- Manage and control documentation, including SOPs, work instructions, and records.
Regulatory Compliance:
- Monitor Regulatory Changes and stay updated on the latest regulatory changes and industry standards, including FDA, ISO, and other relevant regulations.
- Conduct internal audits to assess compliance with regulatory requirements, internal policies, and standard operating procedures (SOPs).
- Develop and implement comprehensive compliance programs, including code of conduct, anti-bribery and corruption policies, and data privacy policies.
- Oversee the regulatory approval process for new products, devices, and clinical trials.
- Respond to inquiries from regulatory agencies in a timely and accurate manner.
Quality Assurance:
- Implement and maintain quality management systems, such as ISO 13485.
- Ensure the quality of products and services through rigorous quality control processes.
- Monitor and manage supplier quality performance and compliance.
- Develop and implement procedures for managing product recalls.
Data Privacy and Security:
- Ensure compliance with data privacy regulations, such as HIPAA and GDPR.
- Implement data security measures to protect sensitive patient information.
- Develop and implement a data breach response plan.
Risk Management
- Conduct Risk Assessment, Identify and assess potential compliance risks.
- Develop and implement strategies to mitigate compliance risks.
- Monitor and review risk assessments and mitigation plans.
Training and Education
- Develop and deliver compliance training programs for employees at all levels.
- Promote a culture of compliance and ethical behavior
- Manage and control documentation, including SOPs, work instructions, and records.
Educational Requirements
- Bachelor’s degree in a law, business, healthcare administration, or a related field.
- Master’s degree is an added advantage.
Professional Requirements
- Certified in Healthcare Compliance
Experience Requirements
- 6 - 8 years’ experience in compliance, quality assurance, or regulatory affairs in the medical device or pharmaceutical industry.
- Strong foundation in healthcare operations, regulations, and ethics.
African Medical Centre of Excellence, Abuja (AMCE Abuja) aims to be an Employer of Choice, providing equal opportunity for everyone regardless of their background, gender, race and other protected characteristics.
