Senior Regulatory Executive - Medical Device

Location: Makarba, Ahmedabad, Gujarat

Employment Type: Full Time

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.
• Assist in the compilation and submission of US FDA 510(k) dossiers, including predicate device analysis and regulatory strategy.
• 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 2-4 years 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.
• Familiarity with FDA 21 CFR Part 820 and 510(k) submission process is a plus.
• Excellent communication, documentation, and project management skills.
• Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.

Skills Required
Iso 14971, regulatory documentation