Regulatory Affairs Expert

vor 1 Woche

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Regulatory Affairs Specialist

As a key member of the PAUL HARTMANN AG team, you will play a crucial role in ensuring the global submission management of our product portfolio.

Key Responsibilities:
  • Act as a primary regulatory contact for business units, regions, and international sales partners, providing expert guidance and support.
  • Manage submission documents with a focus on countries outside the European Union/EFTA, ensuring compliance with relevant regulations.
  • Coordinate submission activities with global colleagues and sales partners, fostering effective collaboration and communication.
  • Accompany and monitor the submission process from application to approval, ensuring timely and successful outcomes.
Requirements:
  • Hold a university degree in a scientific or technical field, such as engineering, biology, or chemistry.
  • Have initial experience in regulatory affairs in the medical devices environment, with a strong understanding of regulatory requirements.
  • Be familiar with regulatory frameworks, such as Regulation (EU) 2017/745 and ISO13485, and able to apply this knowledge in a practical setting.
Benefits:
  • Enjoy flexible working conditions, including flexible working hours and mobile working, allowing for a healthy work-life balance.
  • Take advantage of attractive benefits, such as a company pension plan with employer contribution, childcare subsidy, and 30 days paid leave per year.
  • Benefit from a range of employee perks, including access to fitness and yoga studios, swimming pools, and Crossfit and bouldering halls.

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