Appasamy Associates is hiring an Associate – Regulatory Affairs for its Chennai location. This opportunity is ideal for pharmacy and life sciences professionals with 2-4 years of experience in regulatory affairs, particularly in the medical device industry. Candidates with expertise in regulatory submissions, documentation management, and medical device compliance are encouraged to apply.

This Associate Regulatory Affairs job in Chennai offers an excellent opportunity to work with a leading healthcare and medical device company and contribute to global regulatory compliance and quality healthcare solutions.

Job Details

• Position: Associate – Regulatory Affairs
• Company: Appasamy Associates
• Location: Chennai, Tamil Nadu, India
• Experience Required: 2-4 Years
• Qualification: Bachelor’s or Master’s Degree in Life Sciences, Pharmacy, or a related field
• Industry: Medical Devices, Regulatory Affairs
• Employment Type: Full-Time

Key Responsibilities

Regulatory Coordination

• Track regulatory submissions, including Technical Files, 510(k), CE Marking, and CDSCO applications.
• Maintain regulatory databases and ensure timely updates.
• Monitor global medical device regulatory changes and communicate relevant updates.
• Track project timelines, deliverables, and milestones.
• Collaborate with cross-functional teams to collect required data and documentation.
• Support regulatory strategy execution and monitor progress against regulatory plans.

Administrative Support

• Manage calendars, schedule meetings, and coordinate travel arrangements for the Regulatory Affairs team.
• Prepare and format reports, presentations, and correspondence.
• Maintain physical and electronic filing systems for regulatory and administrative documents.
• Support procurement requests, invoice processing, and budget tracking.
• Assist with internal and external audits by organizing documentation and logistics.

Eligibility Criteria

Candidates applying for the Associate Regulatory Affairs jobs in Chennai should possess:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline.
• 2-4 years of experience in Regulatory Affairs, preferably in the medical device industry.
• Strong organizational and documentation skills.
• Excellent communication and stakeholder management abilities.
• Understanding of medical device regulations, including CE Marking, FDA 510(k), and CDSCO requirements.

Why Join Appasamy Associates?

• Opportunity to work with a reputed medical device organization.
• Exposure to global medical device regulations and compliance processes.
• Collaborative work environment with cross-functional teams.
• Career growth opportunities in Regulatory Affairs and Medical Device Compliance.
• Gain hands-on experience in regulatory submissions and audit management.

How to Apply

Interested candidates can send their updated resume to:

📧 sethuraman.gopal@appasamy.com
📧 careers@appasamy.com

Candidates are advised to mention “Application for Associate – Regulatory Affairs – Chennai” in the email subject line.