QARA Consultant

We are seeking a QARA Consultant to support cross-functional teams in the development, manufacturing, and regulatory submission of combination products.

Key Responsibilities:

• Provide regulatory and quality guidance on combination products, particularly those involving drug-device interactions.
• Support US regulatory specialists in the preparation and submission of NDAs involving combination products.
• Ensure compliance with FDA, EMA, and other global regulatory requirements for combination products.
• Contribute to the design and setup of test systems in electrical manufacturing production units.
• Support drug release processes and ensure compliance with GMP and ISO 13485 standards.
• Act as a knowledge leader, sharing best practices, mentoring team members, and driving continuous improvement.

Contract:

• 18 month contract
• 40 hours per week
• Hybrid role with possibility for remote work