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Company

Over the past 50 years, IMS – part of GMM GROUP –  has invested in research and development, production and quality management, working with radiologists and radiographers to improve image quality and simplify procedures, resulting in more advanced and unique breast imaging technology. Thanks to this continuous commitment, early diagnosis of breast cancer is now possible worldwide, improving women’s health.

IMS GIOTTO works with exclusive suppliers to ensure distribution of our products in over 100 countries worldwide and is part of the GMM Group, a leader in radiological technology.

Position – Role required

IMS GIOTTO is looking for a Technical Documentation Specialist for Radiological Medical Devices.

Job description

The Technical Documentation Specialist is responsible for creating, managing and updating technical documentation for radiological medical devices, with a particular focus on mammography equipment. This specialist will ensure that the documentation complies with current national and international regulations (e.g. MDR – Medical Device Regulation, ISO 13485) and that the devices are ready for CE marking and other required certifications.

Main activities:

• Writing and updating technical files in accordance with the regulatory requirements applicable to mammography radiological devices;
• Collaborate with R&D, Engineering and Quality departments to gather the necessary technical information for documentation;
• Ensure compliance with medical device safety, effectiveness and performance regulations;
• Manage and archive documentation in digital systems that follow good document management practices;
• Monitor and continually update production and test documentation;
• Producing user manuals and operating instructions for healthcare operators and maintenance technicians.

Experience and Skills

• STEM degree or solid experience in medical device technical documentation;
• In-depth knowledge of international medical device regulations (e.g. MDR, FDA);
• Experience in drafting technical documentation for radiological devices, preferably mammography;
• Ability to work in multidisciplinary teams, interacting with engineers, physicists, quality specialists and regulatory affairs experts;
• Excellent knowledge of digital document management tools;
• Attention to detail, accuracy and excellent organisational skills;
• Good command of English (min. B2);
• Excellent verbal and written communication skills,
• Problem solving skills;
• Flexibility and ability to work to tight deadlines.

Other information

• Contract type and compensation are aligned with the applicant’s profile
• The job postings are addressed to both genders in accordance with the laws 903/77 and 125/91, and to people of all ages and nationalities in accordance with the legislative decrees 215/03 and 216/03