CRITICAL CATALYST
1 - 10 employees
📋 Compliance
⚕️ Healthcare Insurance
Compliance • Healthcare Insurance • Regulatory Affairs
CRITICAL CATALYST is a specialized consulting firm focused on regulatory affairs and public health, offering expertise in quality assurance, health safety, and health assessment. The firm provides strategic counseling and project management services to ensure compliance with regulatory requirements across various industries. CRITICAL CATALYST assists companies in navigating the regulatory landscape for medical devices, cosmetic products, food supplements, personal protective equipment, and other health-related products. The company supports businesses throughout the product lifecycle, helping with market access, compliance, and health impact assessments. With a global reach, CRITICAL CATALYST ensures that clients meet all applicable legal requirements efficiently and cost-effectively.
Quality Assurance Officer – Medical Devices
Job not on LinkedIn
🕒 April 1
🗣️🇧🇷🇵🇹 Portuguese Required
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CRITICAL CATALYST
1 - 10 employees
📋 Compliance
⚕️ Healthcare Insurance
Compliance • Healthcare Insurance • Regulatory Affairs
CRITICAL CATALYST is a specialized consulting firm focused on regulatory affairs and public health, offering expertise in quality assurance, health safety, and health assessment. The firm provides strategic counseling and project management services to ensure compliance with regulatory requirements across various industries. CRITICAL CATALYST assists companies in navigating the regulatory landscape for medical devices, cosmetic products, food supplements, personal protective equipment, and other health-related products. The company supports businesses throughout the product lifecycle, helping with market access, compliance, and health impact assessments. With a global reach, CRITICAL CATALYST ensures that clients meet all applicable legal requirements efficiently and cost-effectively.
📋 Description
• Participate in the definition and implementation of Quality Management Systems (QMS). • Prepare Technical Documentation for medical devices (MDs) and software as a medical device (SaMDs) to be submitted to Notified Bodies for CE marking.
🎯 Requirements
• Qualified professionals (QNQ level 6–8) with at least 1 year of experience in Quality Management & Assurance. • Experience developing and implementing Quality Management Systems in accordance with ISO 9001, EN ISO 13485, EN 14971 and EN 62366. • Bachelor’s degree or higher in Health Sciences or Biomedical Technology. • Proficiency in English and Portuguese. • Strong scientific writing skills. • Solid knowledge of the EU regulatory framework for medical devices. • Experience implementing EN 62304 requirements within a Quality Management System. • Experience preparing Technical Documentation for CE marking of SaMDs. • Self-driven, well-organized, and problem-solving oriented.
🏖️ Benefits
• Work on highly innovative products that can make a meaningful difference in people’s lives. • Positive, politics-free work culture based on lean principles and self-organization. • Ongoing training and opportunities for professional and personal development. • Competitive salary and benefits.
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