Regulatory Expert

Job Summary 

The Regulatory Expert will ensure that products, processes, and documentation comply with applicable laws, standards, and industry regulations. 

Key Responsibilities 

• Interpret and implement regulatory requirements relevant to the industry. 
• Prepare and review compliance documentation. 
• Ensure products meet local and international regulatory standards. 
• Coordinate with internal teams during audits and inspections. 
• Track regulatory changes and assess business impact. 
• Develop SOPs, policies, and compliance frameworks. 
• Support risk assessments and quality management processes. 
• Liaise with government bodies, auditors, and certification agencies. 

Required Skill Set 

• Strong knowledge of regulatory frameworks and compliance standards. 
• Experience with ISO standards, FDA, HIPAA, GDPR, CE, MDR, or other applicable regulations. 
• Strong documentation and audit management skills. 
• Ability to interpret legal and technical requirements. 
• Excellent analytical and communication skills. 
• Experience with risk management and quality systems. 

Qualifications 

• Bachelor’s degree in Law, Life Sciences, Pharmacy, Engineering, or related field. 
• Master’s degree or certification in Regulatory Affairs is preferred. 
• 5–10 years of experience in regulatory affairs, compliance, or quality assurance. 
• Relevant certifications such as RAC, ISO Lead Auditor, or compliance certifications are preferred.