Luigi Vecchi

Background

About Luigi Vecchi

Manage an international team of 7 people based in Italy and Germany in order to: Monitor the regulatory compliance worldwide to ensure continual regulatory compliance with Authorities Prepare regulatory submissions world wide to obtain regulatory approval or clearance and contacting the regulatory authorities when needed; Review and approve product labeling, including marketing literature/collateral, as needed, to assure compliance with approved indications and applicable regional regulations. Implement regulatory strategies for product line extensions in support of product development team efforts, and provide guidance to these teams to ensure that development activities are consistent with overall regulatory strategy. Monitor, review and implement new or changed regulatory requirements and proactively advise product development teams of their impact to the business Specialties: Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices and combination products- Ability to function well as a member of the team and build relationships between RA and other areas of the o rganization- Strong computer skills-Ability to train entry-level RA Associates. Strong attention to details, and ability to multitask- Understands the overall business environment and the marketplace