SARA KORFA MALTI

Medical devices registration with Health authorities (EMEA, LATAM, APAC, MENA).

Developed, maintained and updated procedures for registration of products in different countries.

Assisted in the preparation of responses to queries from regulatory agencies concerning product registration applications.

Collaborated with cross-functional teams such as Quality Assurance, Manufacturing, Marketing. to ensure compliance with relevant regulations.

Created reports summarizing regulatory submissions status, timelines and other key information related to projects.

Maintained records of approved documents for all registered products according to local laws.

Implemented indicators to monitor registrations in progress, completed or to be renewed.

Labeling, packaging and promotional documents.

Implemented the UDI system.

Reviewed labeling and promotional materials for accuracy and compliance with applicable regulations.

CE marking and technical files according to Directive 93/42/EEC and the EU Regulation 2017/745

Prepared technical documents including Summary Technical Documents.

Evaluate the impact of modifications to assess their impact on products regulatory status and ensure continued compliance with applicable standards.

Organize regulatory watch

Monitored changes in standards and regulations.

Performed gap analysis and action plan for new applicable standards.

Assisted teacher in creating lesson plans and organizing educational workshops adapted to kindergarten students.

Provided one-on-one support for special needs students.

Facilitated small group instruction sessions on various topics.

Organized inventory control systems to maintain adequate stock levels.

Developed policies and procedures for improving pharmacy organization.

Taking part in continuing education programs to stay up-to-date (diabetes, orthopedics, dermatology).