Senior Regulatory Affairs Consultant

Job Summary

A company is looking for a Senior Regulatory Affairs Consultant - MedTech.

Key Responsibilities

• Lead quality management in development projects related to medical devices
• Collaborate with client teams to ensure adherence to design control and project management processes
• Ensure quality assurance activities and documentation throughout the design and development process

Required Qualifications

• A degree in engineering, Master of Science, pharmacy degree, or similar
• Extensive experience in development (design control) and regulatory submission of medical devices
• Knowledge of MDR, 21 CFR 800-series, ISO 13485, ISO 14971, IEC 62366, and/or IEC 62304
• Fluency in spoken and written English
• A valid work permit for Sweden