Regulatory affairs director Jobs in Kiel
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Regulatory affairs director • kiel
Quality Assurance Manager (m / f / d) – Medical Device Manufacturing
Stryker Trauma GmbHSchönkirchen, GermanySenior Quality Engineer (m / f / d) Medical Devices
Stryker Leibinger GmbH & Co. KGSchönkirchen, Germany- Gesponsert
Praktikum Cyber Security Technology (w / m / d) - IT-Security, Ingenieur
PwC DeutschlandKiel, GermanyQuality Assurance Manager (m / f / d) – Medical Device Manufacturing
Stryker Trauma GmbHSchönkirchen, GermanySenior Director - Technical Services (m / w / d)
ElancoKiel, DEMedical Director (f / m / d) DACH-Region & Netherlands
Ferring PharmaceuticalsKielMedical Director (f / m / d) DACH-Region & Netherlands
Ferring PharmaceuticalsKielPersonalized Internet Assessor - German (DE)
TELUS DigitalKiel, Schleswig-Holstein, dePersonalized Internet Assessor - German (DE)
TELUS DigitalKiel, Schleswig-Holstein, deBrand Director (m / w / d)
IKK - Die InnovationskasseKiel, de, DEDirector Requirements Engineering (m / w / d)
Rohde & SchwarzKiel, Germany(Senior) Consultant Geldwäscheprävention / Compliance (w / m / d)
KPMGKiel, DEPersonalized Internet Assesor-German
TELUS InternationalKiel, Schleswig-HolsteinIT-Consultant Security Regulatory (all genders)
adesso SEKiel, Schleswig-Holstein, DEClinical Research Coordinator- Clinical Research Associate Home-Based
MEDPACEKiel, GermanyOperations Manager
TechBiz Global GmbHKiel, SH, DEIT-Consultant Security Regulatory (all genders)
adesso SEKiel, Schleswig-Holstein, DEÄhnliche Suchanfragen
Quality Assurance Manager (m / f / d) – Medical Device Manufacturing
Stryker Trauma GmbHSchönkirchen, GermanyWork Flexibility : Onsite
As the Quality Assurance Manager (m / f / d) at our Stryker plant in Kiel / Schönkirchen, you will report to the Senior Manager of Quality and collaborate closely with cross-functional teams across Operations, R&D, and Regulatory Affairs. You will lead a local quality team of 6 to 10 professionals and ensure product and process compliance in a highly regulated environment. This is a people leadership role with opportunities to influence decisions, drive quality culture, and develop your team while working in a fast-paced manufacturing setting.
What will you do :
Lead and develop a high-performing team of 6-10 quality professionals, driving strategic initiatives in quality process improvement, validation, compliance, and technology transfers.
Oversee critical QA projects to ensure regulatory compliance while optimizing costs and operational efficiency.
Define and implement a forward-thinking quality system strategy aligned with business needs and global best practices.
Drive continuous improvement initiatives, ensuring robust risk management, NC / CAPA resolution, and quality planning.
Collaborate cross-functionally to ensure adherence to quality standards and regulatory requirements across all operations.
Engage with internal and external audit programs, ensuring the organization maintains all necessary certifications.
Foster a culture of compliance, knowledge sharing, and proactive problem-solving to meet current and future business challenges.
Collaborate with internal and external stakeholders to prioritize tasks, escalate risks, and ensure timely communication.
What will you need :
A university- level Bachelor’s degree in Engineering, Science, or related field.
8+ years of professional experience in a highly regulated industry (e.g. Medtech, Pharma, Food, Automotive or other highly regulated manufacturing environment)
2+ years of experience in people leadership.
Strong understanding of quality principles in manufacturing environments.
Expertise in key quality processes, including Process Risk Management, Validation, Project Management, Non-conformance and continuous improvement etc.
Strong decision-making and prioritization abilities, especially in dynamic, fast-paced manufacturing settings.
Excellent communication and interpersonal skills.
Fluent in English and German, enabling seamless collaboration with global stakeholders.
Expertise in EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards.
Certification in Quality Management (CQE, CQA, Six Sigma Green or Black belt).
Experience working with international authorities during audits / inspections.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
Travel Percentage : 10%