Senior Regulatory Affairs Consultant

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

Jun 10, 2025 - 15:30

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