QA & RA Specialist - Remote

Overview

The QA & RA Specialist is responsible for quality planning, risk analysis, and regulatory compliance in the development projects at Evident, ensuring standards and strategies are met across various disciplines.

In Short

• Conduct quality planning and risk analysis.
• Manage supplier qualifications and audits.
• Lead interdisciplinary project teams for global process standards.
• Coordinate regulatory strategies and compliance programs.
• Support communication with regulatory agencies.
• Participate in product reviews for compliance.
• Manage non-conformities and compliance issues.
• Ensure adherence to safety policies and procedures.
• Work on ISO standards and regulatory requirements.

Requirements

• B.S./B.A in a technical field.
• 5+ years in QA/RA functions in the Life Science industry.
• Knowledge of international regulatory requirements.
• Experience with product and process development requirements.
• Strong organizational and problem-solving skills.
• Excellent verbal and written communication skills.
• Flexibility to travel (20% in Germany, 5% international).

Benefits

• Flexible working hours with 50% remote work possible.
• 30 days of holiday per year.
• 13.5 salaries a year.
• Modern office environment.
• Subsidized meals and transport options.
• Employee Assistance Program for health and well-being.
• Comprehensive company pension scheme.