• Application Deadline:
• Position: Quality & Compliance Manager



• Job Type Full Time



• Qualification BA/BSc/HND , MBA/MSc/MA



• Experience 6 - 8 years



• Location Abuja




• Job Field Legal and Regulatory 
  
  

Job Purpose

• The Quality & Compliance Manager will be responsible for ensuring adherence to regulatory standards, ethical guidelines, and internal policies and procedures. This role requires a deep understanding of regulatory requirements, strong attention to detail, and excellent communication skills.

Core 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 NDPR.


• 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.

Competency Requirements

Knowledge Requirements

• Knowledge of medical terminology to effectively communicate with healthcare professionals and patients.


• Basic understanding of common medical conditions and treatments.


• Knowledge of NDPR regulations and how to handle patient information confidentially.

Skill Requirements

• Excellent communication and interpersonal skills to effectively interact with patients and AMCE staff.


• Problem-solving skills to resolve complex issues.


• Strong attention to detail and ability to multitask.

Personal Abilities

• Professional attitude towards work


• Shares the AMCE’s vision.


• Proactive and organized.


• Has personal and professional credibility and commands the respect of colleagues and peers.


• Supportive and approachable.


• Ability to adapt accordingly.


• High levels of honesty and integrity