Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Manager - Heidenheim an der Brenz, Baden-Württemberg - HARTMANN
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Regulatory Affairs Specialist
vor 3 Wochen
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Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Regulatory Affairs Manager for Post-Market SurveillanceWe are seeking a highly skilled Regulatory Affairs Manager to join our team at PAUL HARTMANN AG. As a key member of our regulatory team, you will be responsible for ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance...
Regulatory Affairs Manager
vor 2 Monaten
About HARTMANN
HARTMANN is a leading global healthcare company committed to delivering innovative solutions that make a real difference in people's lives. We support healthcare professionals in their daily work, enabling them to focus on what truly matters: positively impacting patients.
Our Mission
We strive to be a trusted partner for healthcare professionals, providing them with the tools and expertise they need to deliver high-quality care. Our goal is to be a driving force in shaping the future of healthcare.
Job Summary
We are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulatory requirements for our medical device portfolio.
Key Responsibilities
- Regulatory Expertise: Provide regulatory guidance and support to business areas, regions, and international distributors on global regulatory management of our product portfolio.
- Document Management: Manage necessary regulatory documents focusing on countries outside the European Union/EFTA.
- Collaboration: Coordinate regulatory activities with global colleagues and distributors.
- Process Monitoring: Accompany and monitor the regulatory process from application to approval.
- Knowledge Sharing: Share best practices and collaborate closely with the global RA team.
Requirements
- Education: Successfully completed studies in a scientific or technical field or equivalent.
- Experience: Initial experience in Regulatory Affairs in the Medical Devices sector.
- Knowledge: Knowledge of regulatory requirements for medical devices, e.g., Regulation (EU) 2017/745, ISO.
- Language Skills: Fluent in English and good knowledge of German is advantageous.
What We Offer
- Flexible Working Conditions: Flexible working hours, remote work options.
- International Mobility: Opportunities for international assignments and collaborations.
- Work-Life Balance: Comprehensive benefits package, including childcare allowance, vacation time, and health insurance.
- Professional Development: Opportunities for growth and development in a dynamic and innovative company.