Regulatory Affairs Operations and Labeling Specialist

vor 4 Wochen

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 individuals' lives. Our innovative solutions are designed to create significant change. With your dedication, you can evolve in your position every day. We recognize the extraordinary contributions you can make.

Role Overview:
As a Regulatory Affairs Operations and Labeling Specialist (f/m/d), you will be an integral part of our global team, taking on a diverse and stimulating role within an international framework. Your primary responsibility will be to ensure product excellence and adherence to regulatory standards. If you are passionate about our influential product range, we would love to connect with you. This position also accommodates part-time options.

Key Responsibilities:
  • Guarantee prompt labeling and execution of products in line with regulatory requirements
  • Oversee and improve global regulatory product documentation and compliance
  • Administer master files for package inserts, labels, and artwork, ensuring precision and compliance
  • Propose enhancements to IT systems for managing regulatory product 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
  • Ideally, some experience in the medical device sector or regulatory environments
  • Familiarity with medical devices, technical documentation, and regulatory product documentation
  • Interest in electronic systems for regulatory document management
  • Strong interpersonal abilities and IT skills
  • Proficient in both German and English

Benefits:
  • Flexible working arrangements, including hours and remote options
  • Opportunities for international collaboration
  • Support for maintaining work-life balance
  • Generous leave policies and company pension scheme
  • Various employee benefits, including fitness access and health initiatives
  • Job Bike Leasing
  • Discounts on travel and technology

Shape a fulfilling career centered on healthcare, innovation, and a culture of trust. Become part of something impactful.

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