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Global Regulatory Expert for Medical Devices

vor 2 Monaten


Freiburg, Baden-Württemberg, Deutschland i-Pharm Consulting Vollzeit

About the Role:

i-Pharm Consulting is seeking a highly skilled Global Regulatory Expert for Medical Devices to join our team. As a key member of our regulatory team, you will be responsible for contributing to the creation of technical documentation for existing and new medical devices, as well as implementing the global regulatory strategy.

Key Responsibilities:

  • Develop and maintain technical documentation for marketed and new medical devices, ensuring compliance with regulatory requirements.
  • Collaborate closely with other departments, particularly Production and R&D, to ensure efficient product development and regulatory compliance.
  • Implement and maintain the global regulatory strategy, ensuring alignment with company goals and objectives.
  • Establish and maintain regular contact with relevant regulatory authorities, ensuring timely and effective communication.
  • Serve as the primary point of contact for external stakeholders regarding regulatory matters, providing expert guidance and support.

Requirements:

  • At least 2 years of global regulatory experience in the medical device industry.
  • Excellent knowledge of German language.
  • A proactive and curious mindset, with a strong ability to analyze complex regulatory issues.

About i-Pharm Consulting:

i-Pharm Consulting is a leading consulting firm specializing in pharmaceutical and medical device regulatory affairs. We provide expert guidance and support to clients across the globe, helping them navigate complex regulatory landscapes and achieve their business objectives.