Quality and Regulatory Affairs Manager (m/w/d)

Company Description

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide together with our highly motivated and experienced team of nearly 2’700 employees provide our customers with uncompromising quality, proximity and agility.

As part of the Dental Segment of medmix AG, medmix Deutschland GmbH manufactures and distributes medical devices internationally to the dental industry and dental trade. Around 100 highly motivated, qualified, and experienced employees at the Kiel site ensure the supply of several hundred customers worldwide.

Job Description

​​​​​​Job Description:

• As Department Manager you will lead a team of nine in the areas of Quality Control, Quality Management, and Regulatory Affairs.
• You will be responsible for defining, maintaining, and optimizing QM systems and integrating new standards, systems, and processes where required.
• Defining and managing projects related to QM systems, as well as preparing and maintaining MDR-compliant technical documentation, are core responsibilities.
• You will act as the first point of contact for customers and suppliers on all quality-related or regulatory issues and represent our QM system during customer and authority audits.
• To assess the effectiveness of QM systems and processes, you will prepare regular evaluations and report to higher-level management within the company.
• You will define and provide tools and methods for monitoring QM systems and processes.
• You will support the organization in all regulatory matters and accompany international registrations.
• In your role, you will act as the “PRRC” (Person Responsible for Regulatory Compliance) for our medical devices in classes I, I(s), and II(a).
• You will guide employees in applying established quality methods and conduct training on statistical methods for evaluating experiments, tests, validations, etc.

Qualifications

Qualifications:

• A successfully completed degree, preferably in medical technology, medical devices, or a comparable field in a responsible position.
• At least 5 years of professional experience in Quality Management

• Proven Leadership Experience

• Strong skills in creating and revising documents (SOPs, validation plans and reports, etc.).
• A working style characterized by independence, precision, and reliability in meeting deadlines.
• Motivation and willingness to take on new topics and drive the company forward sustainably.
• Confident in using MS Office and SAP applications.
• Business-fluent German and English skills, both written and spoken

Additional Information

We offer a high degree of responsibility as well as excellent long-term prospects. Competitive compensation and a wide range of social benefits are a given. For example, you can expect:

• A permanent employment contract
• 30 vacation days per year
• Flexible working hours within our flexitime model
• Option to work up to two days a week in a home-office model
• An annual special payment equivalent to a 13th salary
• Employer contributions to capital-forming benefits
• Option of bicycle leasing
• A family-like and secure working environment on site, combined with international career perspectives within the Group
• Support for individual development through targeted internal and external training opportunities

medmix is an equal opportunity employer and is committed to the strength of a diverse workforce.