Job Title: Regulatory Affairs Specialist
Company: Fourth Frontier
Location: Bengaluru
Experience: Minimum 2 years
Qualifications: B.Pharm, M.Pharm, Pharm.D, MSc, BSc
Salary: Not disclosed
Job Description:
Fourth Frontier seeks a Regulatory Affairs Specialist to ensure compliance with FDA, ISO, EU-MDR, and global regulatory requirements. Responsibilities include managing regulatory submissions, developing QMS, and supporting audits and training.
Responsibilities:
| Key Responsibilities | Details |
|---|---|
| Lead regulatory compliance | Ensure adherence to FDA, ISO, EU-MDR, and local regulations. |
| Develop Quality Management System (QMS) | Support QMS development and optimization. |
| Interpret regulatory requirements | Translate ISO 13485, MDSAP, and MDR requirements. |
| Support internal audits and training | Assist in audits, training, and standards reviews. |
| Drive QMS improvements | Identify and implement enhancements for efficiency and effectiveness. |
| Liaise with notified bodies | Manage certification changes and regulatory communications. |
Experience and Qualifications:
- 2+ years in regulated environments.
- Science, Engineering, Business, or related degree.
- Knowledge of US regulations (21 CFR Part 820) and ISO 13485.
- Strong understanding of Quality Systems and compliance.
Skills:
- Compliance and risk management.
- Proficiency in computer applications.
- Occasional travel required.
Apply now to join a dynamic team shaping medical device regulatory compliance at Fourth Frontier.
