Quality & Regulatory Affairs Lead Kiel - Medical Devices

medmix Deutschland GmbH, part of medmix AG, is seeking a Quality & Regulatory Affairs Lead for its Kiel location. This role involves leading a 13-member team in quality control, quality management, and regulatory affairs for medical devices. The successful candidate will be responsible for defining and optimizing QM systems, managing projects, ensuring MDR compliance, and acting as the primary contact for quality and regulatory matters with customers and authorities. The position requires a strong background in medical technology and leadership experience.

Must Have

• Lead a 13-member team in quality control, quality management, and regulatory affairs.
• Define, maintain, and optimize QM systems, integrating new standards and processes.
• Define and lead QMS projects, create and maintain MDR-compliant technical documents.
• Act as the primary contact for quality and regulatory issues with customers and suppliers.
• Represent Quality in customer and authority audits.
• Verify effectiveness of QM systems and processes, report to management.
• Define and provide tools for monitoring QM systems and processes.
• Support international registrations and regulatory matters.
• Serve as "PRRC" (Person Responsible for Regulatory Compliance) for medical devices.
• Guide employees in applying established quality methods and conduct training.
• Technical or scientific degree, preferably in medical technology.
• Many years of professional experience in quality management in medical technology.
• Knowledge of ISO 13485 / MDR / FDA.
• Leadership experience.
• Experience in supplier management.
• Very good MS Office and SAP knowledge.
• Fluent German and English.

Perks & Benefits

• Permanent employment contract
• 30 vacation days per year
• Flexible working hours (flextime model)
• One day per week home office option
• Annual special payment (13th month salary)
• Employer contribution to capital-forming benefits
• Bicycle leasing option
• Family-like and secure work environment with international perspectives
• Support for individual development through targeted internal and external training
• Workplace directly on the Kiel Fjord

Company Description

medmix is a globally leading provider of high-precision application devices. We hold leading positions in the healthcare, consumer, and industrial end markets. Our customers benefit from our commitment to innovation and technological progress, which has resulted in over 900 active patents. Our 14 production sites worldwide and our highly motivated and experienced team of almost 2,700 employees offer our customers uncompromising quality, proximity, and agility.

As part of the Dental segment of medmix AG, medmix Deutschland GmbH produces and distributes medical devices internationally for 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

• Leading a 13-member team in the areas of quality control, quality management, and regulatory affairs
• Responsibility for the definition, maintenance, and optimization of QM systems and, if necessary, integration of new standards, systems, and processes
• Definition and management of projects related to QMS, as well as the creation and maintenance of MDR-compliant technical documents
• First point of contact for customers and suppliers in all quality-relevant and regulatory matters, as well as representing our Quality in customer and authority audits
• Effectiveness review of QM systems and processes, as well as preparation of regular evaluations and reports to company management.
• Definition and provision of tools and methods for monitoring QM systems and processes
• Support for the organization in all regulatory matters and assistance with international registrations
• "PRRC" (Person Responsible for Regulatory Compliance) for our medical devices of classes I, I(s), and II(a).
• Instruction of employees in the application of established quality methods and conducting training courses

Qualifications

• Successfully completed technical or scientific degree, preferably in medical technology or a comparable field
• Many years of professional experience in quality management in the regulated manufacturing industry - in the medical technology sector
• Knowledge of ISO 13485 / MDR / FDA
• Professional experience in a leadership role
• Experience in supplier management
• Very good knowledge of MS Office, as well as SAP knowledge
• Fluent German and English skills

Additional Information

At medmix, you will become part of a renowned team. We offer you a high degree of personal responsibility and excellent future prospects. Adequate remuneration and numerous social benefits are a matter of course for us. For example, you can expect:

• An unlimited employment contract
• 30 vacation days per year
• Flexible working hours within our flextime model
• Possibility for this position to work one day a week in a home office model, as employee-oriented leadership must be ensured
• An annual special payment amounting to a 13th month's salary
• Employer contribution to capital-forming benefits
• The possibility of bicycle leasing
• A familiar and secure working environment on-site with international perspectives within the group
• Support for individual development through targeted internal and external training opportunities
• A workplace directly on the Kiel Fjord

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