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