Key Responsibilities:
- Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports.
- Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies.
- Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes.
- Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards.
- Support the preparation of Notified Body submissions, responses to queries, and audit readiness.
- Interpret global regulatory requirements and translate them into clear guidance and actionable plans for internal and client teams.
Qualifications & Skills:
- Bachelor’s or Master’s degree in life sciences, biomedical engineering, pharmacy, or a related field.
- Minimum 6 months of hands-on experience in regulatory affairs within the medical device industry.
- Demonstrated expertise in EU MDR 2017/745, with experience preparing clinical, risk, and performance documentation.
- Strong understanding of ISO 14971 and MEDDEV guidance.
- Excellent communication, documentation, and project management skills.
- Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.
Job Type: Full-time
Pay: ₹30,000.00 - ₹50,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Provident Fund
Work Location: In person
