Regulatory Affairs Manager

Vor 5 Tagen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland HARTMANN Vollzeit

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.

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