Quality Manager/Regulatory Affairs (m/w/x)

The Hänsler Medical Group has been one of the leading manufacturers of high-quality medical products in complementary medicine for more than 65 years. We supply over 10,000 doctors, clinics, and research institutions worldwide under the brands OZONOSAN, HUMARES, and OZOMED with our ozone therapy devices and the necessary consumables and treatment concepts developed on a scientific basis.

Tasks

Your tasks will include:

• Internal quality management
• Maintenance and expansion of technical documentation
• Preliminary preparation and conduct of audits by the designated authority or government district office
• Audit of suppliers as well as internal audits
• Support in registering products abroad
• Participation in development projects
• Interface function to quality assurance and production

Qualification

Requirements:

• Multiple years of experience in a similar position or with similar responsibility in a medical technology company or at a designated authority
• Very good knowledge of the requirements of ISO 13485 and the MDR (EU 2017/745)
• Good project management skills as well as strong communication skills

Benefits

The company offers very attractive framework conditions and flexible working models.

We look forward to your application

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