Quality Safety & Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
- Bachelors degree with at least a 2:1 grade in relevant field
- Minimum of 5 years experience in Quality Regulatory or Safety roles (healthcare/medical devices preferred)
- Strong knowledge of ISO 9001 ISO 13485 and regulatory frameworks
- Hands-on experience with NAFDAC and external audits
- Proven experience managing QMS CAPA and risk assessments
- Strong leadership communication and documentation skills
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
ISN is the leading supplier of medical diagnostic products and services in Nigeria. The Company is the authorized agent and distributor for major multinationals including Roche Diagnostics GmbH in Nigeria and supplies reagent parameters for clinical chemistry and immunology. ISN emplo ... View more
