Compliance Lead at Deloitte

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.