Quality Safety & Regulatory Affairs Manager at ISN Medical

About the job

• The Quality Safety & Regulatory Affairs Manager will lead and oversee compliance with quality, safety, and regulatory standards, ensuring product integrity and operational excellence. Maintain a robust Quality Management System (QMS) to drive continuous improvement initiatives to enhance safety protocols, mitigate risks, and safeguard stakeholders while maintaining regulatory approvals and industry best practices.

Key Responsibilities

• Ensure adherence to local and international quality and safety regulations.
• Maintain necessary certifications and ensure timely renewals.
• Ensure ongoing compliance with ISO 9001:2015 and ISO 13485:2016 standards.
• Oversee regulatory submissions and approvals with NAFDAC and other relevant authorities.
• Develop and implement quality assurance programs.
• Conduct regular quality checks and audits.
• Maintain and continuously improve the Quality Management System (QMS) in line with ISO 9001:2015 and ISO 13485:2016 requirements.
• Ensure product quality meets established quality and regulatory standards through rigorous inspection, compliance verification, and validation processes
• Monitor and enforce supplier compliance with quality and regulatory requirements to maintain a consistent and reliable supply chain.
• Ensure proper handling & documentation of expired/non-conforming products.
• Work with certified waste disposal vendors for regulatory-compliant destruction.
• Track and report waste disposal compliance to regulatory bodies (e.g., NAFDAC, LAWMA).
• Establish and enforce workplace safety policies.
• Conduct safety training and reviews across all ISN sites and incident investigations.
• Enforce timely completion of administrative tasks related to workplace safety to ensure zero safety incidence across all ISN sites and optimal workplace safety.
• Oversee document control processes to ensure proper storage, retrieval, and updates of quality and regulatory records
• Train employees on regulatory requirements, QMS best practices, and industry standards.
• Lead initiatives to continuously improve quality and safety processes.
• Lead internal audits and coordinate external ISO audits, ensuring full compliance.
• Carry out the duties of the ISO Coordinator according to the requirements of ISO 9001 and 13485.
• Conduct management Reviews of QMS performance and drive continuous improvement initiatives.
• Collaborate with the Senior Internal Audit & Risk Executive to ensure that all high-risk quality issues trigger CAPA investigations.
• Conduct root cause analysis (RCA) and implement risk-based CAPA strategies to prevent recurrence.
• Track CAPA effectiveness and review corrective actions periodically to prevent reoccurrence.
• Oversee CAPA implementation for ISO audit non-conformities and ensure compliance is maintained.