Quality and Regulatory Affairs Manager (mwd)

medmix; Kiel; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading medical technology company in Kiel is seeking a Department Manager for Quality Management. You will lead a team within Quality Control and Regulatory Affairs, ensuring compliance with standards. The role involves optimizing QM systems and being the primary contact for quality issues. Candidates should have a relevant degree and at least five years of experience in Quality Management. This position offers competitive compensation, flexible working hours, and a supportive environment for professional growth.

Leistungen

30 vacation days per year

Flexible working hours

Option for home-office up to two days a week

Annual special payment equivalent to a 13th salary

Employer contributions to capital-forming benefits

Option of bicycle leasing

Support for individual development through training opportunities

Qualifikationen

• Successfully completed degree in medical technology or comparable field.
• At least 5 years of professional experience in Quality Management.
• Proven leadership experience.

Aufgaben

• Lead a team in Quality Control, Quality Management, and Regulatory Affairs.
• Define and optimize QM systems and prepare technical documentation.
• Act as the first point of contact for quality-related issues.

Jobbeschreibung

Responsibilities

• 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

• 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.

Remote Work : No

Employment Type : Full‑time

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Experience : years

Vacancy : 1