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Expert in Regulatory Compliance and Product Labeling

vor 3 Monaten


Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN Vollzeit
Join HARTMANN as a Regulatory Affairs Operations and Labeling Specialist (f/m/d)
At HARTMANN, our mission is to assist , support , safeguard , and develop . We empower healthcare professionals to concentrate on what truly matters: making a positive impact on people's lives. Our innovative solutions are designed to create significant differences in the healthcare landscape. Your dedication can lead to personal and professional growth in your role. We recognize the extraordinary contributions you can make.

Position Overview:
As a Regulatory Affairs Operations and Labeling Specialist (f/m/d), you will be integral to maintaining product excellence and regulatory adherence within our international framework. If you are passionate about our impactful offerings, we would love to hear from you. This position also accommodates part-time arrangements.

Key Responsibilities:
  • Ensure the timely creation and application of product labeling in line with regulatory requirements
  • Oversee and improve global regulatory product documentation and compliance
  • Manage master files for packaging inserts, labels, and artwork, ensuring precision and adherence to standards
  • Propose enhancements to IT systems for managing regulatory documentation
  • Offer strategic and technical guidance on regulatory issues
  • Assess regulatory requirements related to products
Required Qualifications:
  • Degree in scientific or technical disciplines or equivalent experience
  • Ideally, some experience in the medical device sector or regulatory environments
  • Familiarity with medical devices, technical documentation, and regulatory product records
  • Interest in electronic systems for regulatory document management
  • Strong interpersonal abilities and proficiency in IT
  • Fluent in both German and English
What We Offer:
  • Flexible working arrangements, including varied hours and remote options
  • Opportunities for international collaboration
  • Support for achieving work-life balance
  • Comprehensive leave benefits and a company pension scheme
  • Various employee benefits, including fitness access and health initiatives
  • Job Bike Leasing
  • Discounts on travel and technology products
Embark on a fulfilling career focused on healthcare, innovation, and a culture of trust. Become part of something significant.