Regulatory Affairs Specialist | Quality Compliance

🛡️ We’re Hiring: Regulatory Affairs Specialist | Quality Compliance🕒 Employment Type: Full-Time💼 Level: Mid-LevelWe are looking for a detail-oriented and compliance-focused Regulatory Affairs Specialist | Quality Compliance to support regulatory submissions, compliance monitoring, quality systems, and regulatory requirements. The ideal candidate will work closely with internal teams and regulatory authorities to ensure products, processes, documentation, and business activities meet applicable regulatory and quality standards.🎯 Key Responsibilities

• Monitor applicable regulatory requirements, standards, guidelines, and industry developments.
• Support regulatory submissions, registrations, renewals, amendments, and product approvals.
• Prepare, review, and maintain regulatory documentation and submission packages.
• Ensure regulatory records, licenses, certificates, and approvals remain accurate and up to date.
• Monitor changes in regulatory requirements and assess their potential impact on business operations.
• Communicate regulatory updates and compliance requirements to relevant internal departments.
• Support the development, implementation, and maintenance of quality management systems.
• Monitor compliance with internal policies, procedures, regulatory requirements, and quality standards.
• Conduct compliance reviews, internal assessments, and quality checks to identify gaps.
• Support internal and external audits, inspections, and regulatory assessments.
• Prepare audit documentation and coordinate responses to findings, observations, and corrective actions.
• Track Corrective and Preventive Actions (CAPA) and ensure timely completion of assigned actions.
• Assist with deviation, non-conformance, complaint, and quality-incident investigations.
• Support root-cause analysis and recommend appropriate corrective and preventive measures.
• Review Standard Operating Procedures, work instructions, forms, and quality-related documents.
• Maintain document-control systems and ensure controlled documents are properly approved and distributed.
• Coordinate change-control activities and assess regulatory or quality impacts of proposed changes.
• Review product labels, packaging materials, technical documents, and marketing claims for regulatory compliance where applicable.
• Maintain regulatory databases, compliance records, quality documentation, and submission tracking systems.
• Liaise with regulatory authorities, certification bodies, auditors, consultants, and external partners when required.
• Support product lifecycle management activities including new product introductions, modifications, renewals, and discontinuations.
• Monitor quality and compliance KPIs and prepare regular reports for management.
• Provide regulatory and quality-compliance guidance to product development, manufacturing, operations, procurement, and commercial teams.
• Support supplier and third-party compliance activities, including qualification and documentation reviews.
• Identify potential regulatory and quality risks and recommend appropriate mitigation measures.
• Promote a strong culture of regulatory compliance, quality awareness, and continuous improvement across the organization.✅ Requirements
• Diploma or Bachelor’s degree in Regulatory Affairs, Quality Management, Life Sciences, Pharmacy, Chemistry, Engineering, Healthcare, or a related field.
• Previous experience in regulatory affairs, quality assurance, compliance, or a related regulated industry.
• Good understanding of regulatory frameworks, quality management systems, and compliance principles.
• Experience preparing and maintaining regulatory submissions and compliance documentation.
• Familiarity with standards such as ISO 9001, ISO 13485, GMP, GxP, or other relevant regulatory frameworks is an advantage.
• Strong document-management and record-keeping skills.
• Excellent attention to detail and commitment to accuracy.
• Strong analytical and problem-solving abilities.
• Ability to interpret regulatory requirements and translate them into practical business actions.
• Experience supporting internal and external audits or regulatory inspections.
• Familiarity with CAPA, deviation management, change control, risk assessment, and non-conformance processes.
• Strong written and verbal communication skills.
• Ability to communicate effectively with regulatory authorities, auditors, suppliers, and internal stakeholders.
• Strong organizational and time-management skills.
• Ability to manage multiple regulatory submissions, compliance projects, and deadlines.
• Proficiency in Microsoft Office, document-management systems, and quality-management software.
• Strong ability to maintain confidential regulatory and business information.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Professional certification in regulatory affairs, quality management, compliance, or auditing is an advantage.
• Experience in pharmaceuticals, medical devices, biotechnology, healthcare, food, cosmetics, manufacturing, or other regulated industries is a plus.🌟 What We Offer
• Competitive salary and comprehensive employee benefits.
• Professional training in regulatory affairs, quality management, and compliance.
• Exposure to regulatory submissions, audits, inspections, and quality systems.
• Opportunities to work with regulatory authorities, auditors, certification bodies, and industry partners.
• Support for professional certifications and industry-related training.
• Opportunities to participate in quality improvement and regulatory transformation projects.
• Supportive and collaborative compliance environment.
• Exposure to cross-functional projects involving operations, manufacturing, product development, and business teams.
• Career development opportunities within regulatory affairs, quality assurance, and compliance.
• Opportunities to develop expertise in international regulatory standards and quality systems.
• Performance recognition and long-term career advancement opportunities.