Director of Regulatory Affairs in Marburg

vor 4 Wochen

Marburg an der Lahn, Hessen, Deutschland Siemens Healthcare Diagnostics Products GmbH Vollzeit

Are you driven by the desire to influence the healthcare landscape? Siemens Healthcare Diagnostics Products GmbH is seeking a Director of Regulatory Affairs in Marburg to uphold the excellence of our offerings for clients worldwide.

Key Responsibilities:

  • Oversee the Regulatory Affairs division in Marburg, managing global product registrations for hematology, hemostasis, and plasma protein IVD solutions.
  • Facilitate prompt market entry for both US and international territories, lead regulatory initiatives, and enhance strategies for quicker time-to-market.
  • Stay abreast of regulatory changes, engage with industry bodies, and foster relationships with Health Authorities.
  • Provide insights to the Quality Head and Management Review, represent Marburg in FDA interactions, and coordinate with the Global Regulatory Affairs team.

Qualifications:

  • A minimum of 10 years in Regulatory Affairs, with at least 8 years in the Healthcare sector or a related domain.
  • Deep knowledge of regulatory processes, FDA engagement, and familiarity with standard regulatory frameworks.
  • Proven experience in steering complex projects and leading cross-functional teams.

Skills:

  • Fluency in both English and German.
  • Strong communication, conflict resolution, and negotiation capabilities.
  • Exceptional leadership, flexibility, and strategic planning skills.
  • Proactive, able to thrive under pressure, and innovative in problem-solving.

Siemens Healthcare Diagnostics Products GmbH stands at the forefront of medical technology, with a diverse and dynamic workforce committed to transforming healthcare. Embrace new challenges, contribute your insights, and be part of a culture that encourages open dialogue and innovation.

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