Compliance Lead at the African Medical Centre of Excellence, Abuja (AMCE Abuja) - Deloitte Human Capital Consulting

Deloitte Human Capital Consulting - Our client, the African Medical Centre of Excellence, Abuja (AMCE Abuja), is a quaternary-level multi-specialty medical institution developed by Afreximbank aims to revolutionize healthcare in Africa. Established to address critical gaps, the AMCE Abuja is committed to providing world-class care through innovative research, development, and education. The Centre will offer comprehensive services in oncology, haematology, cardiovascular care, and general healthcare across the continent, with plans for expansion. The construction phase, supported by global partners, precedes a phased rollout over six years, evolving into a 500-bed facility.

Set to commence operations in early 2025, this flagship facility in Abuja is a key part of Afreximbank’s network of healthcare facilities, actively countering brain drain, reducing medical tourism by offering advanced procedures such as stem cell transplantation and state-of-the-art treatments for various diseases, and fostering employment opportunities. The vision for the AMCE initiative is to shape a healthier and more educated future for Africa.

They are recruiting to fill the position below:

Job Title: Compliance Lead

Location: Abuja
Job type: Full-time

Responsibilities
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.

Qualifications
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.

Application Closing Date
Not Specified.