Regulatory and Quality Specialist (Ventilation)

Category: Full-time, Contract
Start date: 15.5.2022
Remuneration: 2,500 € gross depending on contract type

Key attributes we would look for:

• Proven track record of regulatory submissions of technical files
• Proven track record of preparing for and managing successful Quality audits / inspections
• Experience in medical device design and manufacturing of capital equipment and sterile medical devices is strongly preferred
• Experience with Quality Management Systems for medical devices
• Experience as a quality / regulatory affairs manager in the medical device industry or a similar level in a healthcare facility, a regulatory body or a healthcare authority

Responsibilities:

You will lead the overall Quality and Regulatory compliance effort at IPM Chirana. Specifically you will be responsible for coordinating and directing the IPM Chirana program designed to ensure quality production of medical devices compliant and consistent with established standards of applicable regulatory agencies. This includes:
• Demonstrating and earning CE Mark, ISO 13485 certification
• Implementation of ISO 13485 Quality Management Systems;
• Assuring that manufacturing is following all quality assurance processes and procedures resulting in manufacturing quality medical devices
• Implementation of the European Medical Device Regulations;
• Gather, create, and review technical documentation;
• Conduct internal audits at the company’s site;
• Stay up-to-date on changes to the European Medical Device Regulations and related standards.

The successful candidate would hope to gain:

Co-creation of the processes, your ideas is what we need.
Professional growth through in-house and external trainings, conferences and just from everyday work with top business professionals from all over the world.
Flexibility in working hours, we are a result-driven organization and let our employees manage their time.
Rapid personal and career growth.
Financial contribution to health/sport/education based on your choice.

Contact us

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