Regulatory Affairs Specialist

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 new 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