Position: Regulatory Affairs Specialist

Location: Kochi

Qualification: Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Engineering, Life Sciences, or related field

Experience: Min 3 years of Regulatory Affairs experience in the medical device industry

Salary : 8 LPA (Negotiable)

Job Summary:
We are looking for a Regulatory Affairs Specialist with experience in the medical device industry. The person will support global regulatory submissions, product registrations, regulatory compliance, complaints, and post-market surveillance.

Key Responsibilities:
Handle regulatory activities for US FDA, EU MDR, Health Canada, UK, and other countries.
Prepare documents for FDA 510(k), technical files, design dossiers, and regulatory submissions.
Manage product registrations, establishment registrations, licenses, and renewals.
Review product, manufacturing, supplier, labeling, and QMS changes for regulatory impact.




Support recent product launches and international market registrations.
Review customer complaints and assess regulatory reportability.
Support post-market surveillance, complaint investigations, and root cause analysis.
Prepare PMS Reports and PSURs.
Monitor changes in regulations and regulatory standards.
Maintain regulatory records and documentation.
Support regulatory and quality audits.

Requirements:
Experience with FDA 510(k) or international regulatory submissions.
Experience in global product registrations and regulatory licenses.
Experience with regulatory assessment of product/QMS changes.
Experience in complaint evaluation and post-market surveillance.
Knowledge of FDA, EU MDR, Health Canada, and UK medical device regulations.
Knowledge of ISO 13485 and FDA QMSR

📌 Regulatory Affairs Specialist Kochi
🏢 HIRESTAR JOB BANK
📍 Kochi