Regulatory Expert

Imagevision; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Imagevision in Hyderabad is seeking a Regulatory Expert to ensure that products, processes, and documentation meet applicable laws, standards, and industry regulations. You will interpret regulatory requirements, prepare and review compliance documentation, coordinate audits with certification bodies, track regulatory changes, and develop SOPs, policies, and quality systems to support risk management.

A Bachelor’s degree in Law, Life Sciences, Pharmacy, or Engineering is required; a Master’s in

Qualifications

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

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.

Skills

Regulatory frameworks

Documentation & audits

Legal/technical interpretation

Analytical & communication

Risk management & quality

Education

Bachelor’s degree in Law/LS/Pharmacy/Engineering

Master’s degree or RAC certification

Job description

Job Summary

The Regulatory Expert will ensure that products, processes, and documentationcomply withapplicable 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’sdegree 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.