Do you want to contribute to the future success of LEO Pharma within medical device and drug-device development?

Medical Device Specialist

Your main tasks:

• development and maintenance of medical devices in compliance with current regulatory and GMP requirements and standards securing quality, reliability and launch readiness
• executing technical tasks related to medical device development, e.g. mechanical and functional design as well as specification, testing & verification
• establish, review and maintain technical documentation supporting regulatory approval of medical device or drug-device combination products worldwide
• involved in development and maintenance of medical device, drug-device combination products and primary packaging in compliance with current regulatory requirements and standards ensuring quality, reliability and launch readiness
• transfer of the technical documentation, including all relevant product and manufacturing specifications from the development phase into the product manufacturing and maintenance phases
• optimise/upgrade medical device products as part of life-cycle management and maintain related documentation

 Your qualifications:

• relevant academic background (engineering degree or similar)
• some knowledge of and experience with technical areas related to medical device/drug-device combination product development; solid knowledge of and experience with compliance engineering and technical documentation, such as design history file, risk management file, usability, verification, validation and change management
• experience with regulatory authorisation procedures and dialogue with authorities
• good communication skills in English both in writing and verbally and the ability to engage with people and influence across the organisation
• project management would be an advantage
• team player with focus on delivering quality in own tasks
• thrives in a dynamic work environment with ambitious colleagues and many projects

Pharmaceutical Product Support 
PPS is part of Global Development, counting 45 persons divided into four sections. We provide fast, efficient and qualified pharmaceutical, analytical, device and packaging related support and documentation regarding marketed products at LEO Pharma. The team in the section will be responsible for the finalisation and maintenance of the documentation to be made for medical devices, primary packaging and drug-device combination products in close collaboration with other departments. Furthermore, the responsibility of the team will be to provide support to and documentation of packaging materials for pharmaceutical products on the market.

We look forward to receiving your application.