Regulatory Affairs Specialist - Italy
Want to know company name or location? Company managed [?]
Your Mission Support the regulatory affairs team in managing the regulatory submission process for IVD products registration at worldwide level
- Prepare registration dossiers to achieve timely regulatory approvals and maintenance of the existing product licenses in international markets
- Work closely with product development, marketing and other teams ensuring strategy falls in line with regulatory requirements through the whole product lifecycle
- Collaborate in keeping company informed of regulatory requirements in the EU and international markets
- Review Change Orders and assess regulatory impact of product changes and manage related submissions Review proposed labeling for compliance with applicable regulations.
- Ensure compliance with applicable EU and international law/standards. Support the participation to tenders
- Support post-marketing vigilance activities
Master's Degree: Chemistry, CTF, Biology or equivalent
Master in Regulatory Affairs
Preferably 2-3 years experience in a regulatory affairs position in the pharmaceutical, healthcare or medical device/IVD sector.
- Knowledge of quality management systems and current International and European regulations with respect of in vitro diagnostics/medical devices
- Experience using Microsoft Office programs
- Good organizational skills in order to meet the assigned projects
- Strong analytical thinking
- Good problem solving attitude and understanding of priorities
- Effective communication skills and interpersonal skills with sense of responsibility
- Ability to work independently and as a part of a team
Fluent spoken and written Italian and English. Spanish or German is a plus.
some travel will be required