Objective
The Quality & Regulatory (Q&R) manager leads all the Q&R related activities in Xyall. The manager will be responsible that all products of Xyall adheres to the legal requirements of countries, where Xyall is active. Next, the Q&R manager will maintain the Quality Management System of Xyall; Xyall is ISO 13485 certified. Also the records to support the evidence, that Xyall actively uses and adheres to its QMS, need to be controlled by the Q&R manager. Products and organisation need to adhere to Good Manufacturing Practices. The manager makes sure that all employees of Xyall are properly trained concerning the QMS and other relevant Q&R related matters, and will keep contact with the suppliers of Xyall, notified bodies and others external parties concerning Q&R matters.
Key Areas of Responsibility
- Manages all regulatory affairs, that are relevant for Xyall.
- Developing, Implementing and Maintaining the Quality Management System per relevant standards and regulations (ISO 13485 and FDA 21 CFR 820)
- Manages and maintains documentation related to quality processes, procedures, and product records
- Prepares all relevant audits and will do the follow-up of the actions (ISO 13485, Supplier audits, internal audits, etc)
- Ensures that all documentation, including Design History Files, Device Master Records, Device History Records, is complete, accurate, up-to-date, and accessible to relevant stakeholders
- Makes sure that all major suppliers and partners adhere to the Q&R requirements of Xyall
- Development and maintenance of technical files for regulatory compliance
- Obtain and maintain product registration (EU and US)
- Manages all contacts with Notifies bodies
Placement in the Organization
Member of the Management Team. Manager of the Q&R activities. Reports to the COO of Xyall.
Requirements
- Proven experience in both areas of Quality Assurance and Regulatory Affairs
- Experience with obtaining regulatory compliance in the US and EU market
- Experience in Healthcare/Medical Devices
- Has a strong affinity with technology and experience in working with R&D and M&S
- Result driven; “get things done” mentality
- Good analytical and communication skills
- Likes to work for a start-up company; flexibility in such an environment is required
- At least three days per week presence in the office in Eindhoven
- Education level: at least BSc
- Affinity with High-Tech