This position is responsible for assisting in the preparation and submission of EU notification as per MDD 93/42. The candidate must have a basic working knowledge of MDD 93/42.
Responsible for assisting in the preparation and compilation of EU notification documents and forms This job has no supervisory responsibilities
Bachelor's Degree (BA/BS) from four-year college/university or equivalent.
One year related experience and/or training preferred; or equivalent combination of education and experience Sounds experience in MDD compliance. MDR knowledge is a plus.
At least 1 year experience of working in Regulatory Affairs Management within a MedTec company biopharmaceutical or biotechnology areas
Language Skill: fluent in English and Italian
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to read, analyze, and interpret regulation requirements.
Ability to effectively present information to peers.
Good prioritizing, organization, interpersonal, communication and analytical skills;
Must have the ability to work in a team-oriented environment and is able to meet tight deadlines.
Building internal working relationships with all department levels.
Good computer skills (MS Office); Able to work in an high demanding environement and in a matrix organization The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.