Regulatory Affairs Specialist | Quality Compliance
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Key skills for this role
Role Overview
Support regulatory submissions, compliance monitoring, quality systems, and regulatory requirements.
Work with internal teams and regulatory authorities to maintain compliance across products, processes, documentation, and business activities.
The role is described as full-time and mid-level.
Key Skills for This Role
Full Job Posting
Role Overview
Support regulatory submissions, compliance monitoring, quality systems, and regulatory requirements.
Work with internal teams and regulatory authorities to maintain compliance across products, processes, documentation, and business activities.
The role is described as full-time and mid-level.
Regulatory Responsibilities
- Monitor regulatory requirements, standards, guidelines, and industry developments.
- Support submissions, registrations, renewals, amendments, and product approvals.
- Prepare and maintain regulatory documentation and submission packages.
- Maintain licenses, certificates, approvals, regulatory databases, and submission tracking systems.
- Assess regulatory changes and communicate their impacts to internal departments.
- Liaise with regulatory authorities, certification bodies, auditors, consultants, and external partners.
Quality and Compliance Responsibilities
- Support quality management systems and monitor compliance with policies, procedures, regulations, and quality standards.
- Conduct compliance reviews, internal assessments, quality checks, audits, and inspections.
- Prepare audit documentation and coordinate responses to findings, observations, and corrective actions.
- Track CAPA and support investigations into deviations, non-conformances, complaints, and quality incidents.
- Coordinate document control, change control, risk assessments, and supplier compliance activities.
- Monitor KPIs, recommend risk mitigations, and promote continuous improvement.
Requirements
- Diploma or bachelor's degree in a relevant regulatory, quality, scientific, engineering, healthcare, or related field.
- Experience in regulatory affairs, quality assurance, compliance, or a regulated industry.
- Understanding of regulatory frameworks, quality management systems, and compliance principles.
- Experience with regulatory submissions, compliance documentation, audits, inspections, CAPA, deviation management, change control, and risk assessment.
- Strong documentation, communication, analytical, organizational, and time-management skills.
- Proficiency in Microsoft Office, document-management systems, and quality-management software.
- Ability to manage confidential information, multiple deadlines, and cross-functional collaboration.
- Familiarity with ISO 9001, ISO 13485, GMP, GxP, or other relevant frameworks is advantageous.
- Professional certification in regulatory affairs, quality management, compliance, or auditing is advantageous.
- Experience in pharmaceuticals, medical devices, biotechnology, healthcare, food, cosmetics, manufacturing, or another regulated industry is advantageous.
What We Offer
- Competitive salary and comprehensive employee benefits.
- Professional training and exposure to submissions, audits, inspections, and quality systems.
- Support for professional certifications and industry-related training.
- Opportunities to participate in quality improvement and regulatory transformation projects.
- Career development within regulatory affairs, quality assurance, and compliance.
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