Technical Writer & Regulatory Affairs Support

We are looking for a Technical Writer & Regulatory Affairs Support to expand our Regulatory team.

As a member of the Regulatory area in our Software Research and Development Department, you will directly write the technical and user manuals of all our products as well as the department technical documentation.

Besides, you will support your senior colleagues in their activities.

Main activities:

  • Research, define, write and modify new and existing content, working in close contact with various company departments
  • Gather information to develop, organize and write technical and user manuals, technical specifications and articles
  • Develop content in alternative multimedia formats to maximize usability, in accordance with all the product documentation
  • Support the activities of the Regulatory department in medical device software marking activities according to the EU Regulation 2017/745, FDA and other extra-EU countries’ regulations

Requirements:

  • Bachelor’s degree in biomedical engineering or similar background
  • Excellent knowledge of the English language
  • Proficient with the use of PCs, Office bundle: Excel, Word, e-mail
  • Interested in working in the regulatory field and in technical and scientific writing
  • Passion for software
  • Previous experience in the regulatory field, preferably in the medical device sector, is a plus

Required skills:

  • Excellent relational and communication skills
  • Excellent writing skills
  • Organizational skills and accuracy
  • Teamworking
  • Initiative
  • Attitude to learning and continuing education

The job is based in: Lecco

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