QA/RA Manager

Drive quality and regulatory excellence in precision skin analysis and skin treatment devices

As QA/RA Manager at Cortex Technology ApS, you will drive overall quality assurance and support regulatory affairs activities, including regulatory approvals, quality management system compliance, product quality, and workflow optimisation. You will work closely with the departments, ensuring compliance with relevant regulations and standards.

With direct report to the CEO, you are the QA/RA advocate that guides Cortex and ensures that the quality management system operates efficiently and supports business objectives.

Your main tasks are:

• Improve, develop, and implement quality assurance processes (ISO 13485) aligned with business strategy and priorities.
• Manage CAPA processes, complaints, NCRs, and statistical data analysis.
• Improve and implement the Quality Management System infrastructure and educate the organisation.
• Ensure proper preparation and maintenance of technical documentation in collaboration with other departments.
• Manage the quality management system (ISO 13485), including process optimisation and system improvements.
• Lead audits (internal, external, and supplier audits).
• Conduct and facilitate risk analyses.
• Handle regulatory tasks.

Your qualifications are more than 5 years of experience in quality management (ISO13485) and regulatory compliance (MDR, FDA 21 CFR Part 820), preferably within the medical device or a related industry. Experience with quality management systems and a solid understanding of the CAPA processes, complaints handling, and statistical data analysis are essential.

You are a person with a strong analytical mindset and a structured, self-driven approach. You possess a very team-minded and hands-on attitude and an action-oriented working style; a collaborative and action-oriented one is crucial for achieving the defined goals for this role.

Cortex Technology offers exciting opportunities for professional growth and development. You will be able to shape and optimise quality and regulatory processes, contributing directly to the company's global ambitions.