Job Overview

Location
Lagos, FCT
Job Type
Full Time
Date Posted
1 year ago

Additional Details

Job ID
108755
Job Views
49

Job Description






Job Description



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.



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