If you’re looking for a Regulatory Affairs Associate job in the medical device industry, Aurolab is hiring experienced professionals in Madurai, Tamil Nadu. This is an excellent opportunity for candidates with 1–3 years of Regulatory Affairs experience in medical devices or healthcare who want to work with ISO 13485, US FDA 21 CFR Part 820, EU MDR, and 510(k) submissions.

The Regulatory Affairs Associate will play a key role in ensuring regulatory compliance, preparing technical documentation, supporting audits, and coordinating with cross-functional teams to maintain global regulatory standards.

Job Highlights

Key Responsibilities

The selected candidate will be responsible for:

• Implement ISO 13485, US FDA 21 CFR Part 820, and EU MDR regulatory requirements.
• Maintain regulatory documentation and records for compliance.
• Prepare and update documentation for ISO 13485, EU MDR, and US FDA 510(k) submissions.
• Respond to regulatory authority queries from US FDA and Notified Bodies.
• Support regulatory inspections, external audits, and internal compliance activities.
• Maintain audit reports and regulatory documentation.
• Collaborate with Quality Assurance, Clinical, Regulatory Affairs, and cross-functional teams.
• Assist the Regulatory Affairs Manager with regulatory projects.
• Support CAPA implementation and follow-up for audit observations.
• Ensure continuous compliance with global medical device regulations.

Qualifications

Candidates should possess:

• Bachelor’s or Master’s degree in B.Pharm, M.Pharm, Biomedical Engineering, Life Sciences, Biotechnology, Medical Devices, or related healthcare disciplines.
• 1–3 years of Regulatory Affairs experience in medical devices or healthcare.
• Knowledge of:
  • ISO 13485
  • US FDA 21 CFR Part 820
  • EU MDR
  • US FDA 510(k)
• Strong documentation and communication skills.
• Good understanding of regulatory compliance systems.
• Proficiency in Microsoft Office.

Preferred Skills

• Regulatory documentation
• Medical Device Regulatory Affairs
• FDA Compliance
• EU MDR
• ISO 13485
• CAPA Management
• Audit Support
• Technical Documentation
• Regulatory Submission
• Cross-functional Coordination
• Problem Solving
• Communication Skills

Why Join Aurolab?

Aurolab offers professionals an opportunity to work in an internationally regulated medical device environment where employees gain exposure to:

• Global Regulatory Affairs
• US FDA Compliance
• EU MDR Regulations
• Medical Device Quality Systems
• International Product Registrations
• Cross-functional regulatory projects
• Career growth in Regulatory Affairs

Salary (Estimated)

Based on similar Regulatory Affairs roles in India’s medical device industry:

₹4.8 LPA – ₹7.8 LPA (Estimated CTC)

Actual compensation may vary depending on experience, qualifications, and company policy.

How to Apply

HR Manager
Aurolab, No. 1, Sivagangai Main Road,
Veerapanjan, Madurai – 625 020
Email: ta@aurolab.com or jayasree@aurolab.com

Application Link