Africure Pharmaceuticals
Urgently Required
Regulatory Specialist – Pathology
Experience : 1 to 5 years
No of vacancies : 1
Job Description: The Regulatory Specialist ensures that healthcare and pathology laboratories comply with local, national, and international regulatory requirements. This role involves preparing and submitting documentation, maintaining compliance with industry standards, and liaising with regulatory authorities to secure and maintain necessary certifications and approvals.
Key Responsibilities: Documentation Preparation: Prepare, review, and submit regulatory documentation for compliance with NABL, CAP, ISO, CLIA, and other standards.
Regulatory Monitoring: Stay updated on changes in regulatory requirements and standards that impact laboratory operations.
Certification Maintenance: Ensure the laboratory maintains all necessary certifications and accreditations.
Audit Support: Assist with internal and external audits, ensuring that all regulatory requirements are met.
Policy Development: Develop and update standard operating procedures (SOPs) to align with regulatory guidelines.
Liaison Role: Act as a point of contact with regulatory bodies and accreditation agencies.
Training: Educate laboratory staff on regulatory requirements and compliance standards.
Risk Management: Identify areas of non-compliance and work with teams to implement corrective actions.
Quality Assurance: Collaborate with quality assurance teams to ensure regulatory standards are integrated into laboratory processes.
Reporting: Generate reports and summaries for regulatory submissions and management review.
Education Qualifications: Minimum Requirements: Bachelor’s degree in Healthcare Administration, Life Sciences, or a related field.
Preferred: Master’s degree or certifications in regulatory affairs, such as RAPS (Regulatory Affairs Professional Society) or RAC (Regulatory Affairs Certification).
Experience: Proven experience in regulatory compliance or quality management roles, preferably in the healthcare or pathology sector.
Key Attributes: Attention to Detail: High precision in preparing and reviewing regulatory documentation.
Communication: Strong skills for interacting with regulatory agencies and educating staff.
Analytical Skills: Ability to interpret complex regulatory requirements and implement them effectively.
Problem-Solving: Capacity to address and resolve compliance challenges.
Organizational Skills: Ability to manage multiple deadlines and maintain accurate records.
Adaptability: Flexibility to respond to evolving regulatory changes and requirements.
About the Role: The Regulatory Specialist plays a vital role in ensuring that the laboratory adheres to all applicable regulations, enabling smooth operations and maintaining the organization’s reputation for compliance and quality.