Quality and Regulatory Affairs Manager (mwd)

Kiel - Germany

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 :

Employment Type :

Full-time

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 re...

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 :

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

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About Company

Medmix

medmix es líder mundial en dispositivos de administración de alta precisión, con posiciones de liderazgo en los mercados finales de la sanidad, consumo y la industria.Nuestros clientes se benefician de nuestra orientación a la innovación y al avance tecnológico, que se ha traducido en ... View more

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