Quality Assurance Officer - Medical Devices (m/f)

CRITICAL CATALYST is a team of specialised consultants in regulatory affairs for the Medical Devices industry. We provide strategic counselling and tailored project management to ensure compliance with regulations and market access requirements for our client's products and services. Our mission is to create a clear path for businesses fast-forward through the global regulatory complexity.

As Quality Assurance Officer, you will participate in the definition and implementation of Quality Management Systems (QMS) and preparation of Technical Documentation for MDs and SaMDs to be submitted to Notifying Bodies for CE marking purposes.

Baseline Profile

• Qualified professionals (QNQ level 6-8) with Quality Management & Assurance experience (minimum 1 year) in developing and implementing Quality Management Systems according with ISO 9001, EN ISO 13485, EN 14971 and EN 62366

• Health Sciences or Biomedical Technology bachelor's degree or higher
• English and Portuguese language proficiency
• Proficient scientific writing skills

Highly Valued

• Solid knowledge of the regulatory framework applying to medical devices in the EU market
• Experience in the implementation of EN 62304 requirements within a Quality Management System
• Experience in the preparation of Technical Documentation for CE marking purposes of SaMDs
• Self-driven, self-organized and problem-solving oriented

Benefits

• Working in highly innovative products that can make a difference in people's lives.
• Positive and politics-free work culture built on the principles of lean and self-organisation
• Training, professional and personal skills continuous development
• Competitive salary and benefits

Our projects are mainly based in the European Union, United Kingdom and United States. We support self-management and cooperation, while respecting everyone's identity, beliefs and ideas. We strive to create a positive environment for our employees, supporting their professional growth and personal development.