Roles and Responsibilities:
- Lead CE certification projects
- Prepare technical documentation
- Liaise with Notified Bodies
- Conduct gap analysis
- Handle audit responses
- Maintain compliance records
- Support surveillance audits
- Review product classifications
- Train junior consultants
- Manage multiple projects
- Ensure regulatory timelines
Qualifications and Skills:
- 2+ years of regulatory and quality assurance experience
- CE Certification experience mandatory
- Knowledge of USFDA 510k will be a plus
- Strong regulatory knowledge
- Documentation excellence
- Client coordination
Job Type: Full-time
Pay: ₹30,000.00 - ₹50,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Provident Fund
Work Location: In person
