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.