Carolina Santos Email & Phone Number

Morges

- Management and support of medical devices (MD) registration to obtain approvals and enable commercial distribution of products in EIMEA markets: - Perform and facilitate MD registration activities by coordinating with distributors to compile appropriate dossiers, submissions and responses to regulatory bodies - Prepare, submit, and maintain CE certifications (MDD compliant) through product technical files update - Conversion and harmonization of the MD… Show more - Management and support of medical devices (MD) registration to obtain approvals and enable commercial distribution of products in EIMEA markets: - Perform and facilitate MD registration activities by coordinating with distributors to compile appropriate dossiers, submissions and responses to regulatory bodies - Prepare, submit, and maintain CE certifications (MDD compliant) through product technical files update - Conversion and harmonization of the MD technical files in compliance with the EU Medical Device Regulation (MDR)- Support authorized representative activities, such as management of CH Rep Agreement - Accountable for management-coordination of complaints and medical device vigilance reporting, with appropriate documentation and maintenance to ensure a constant state of inspection readiness- Audit backroom support management of both notified bodies and internal audits- Participation in regulatory affairs working groups of EU trade associations (COCIR) for guidance and support of the EU MDR implementation, Brexit and MDR Swixit RA assessment- Building Regulatory Intelligence database with continuous research insights of international government expectations, regulations and directives that have an impact in the product or business objectives.Regulatory Affairs Champion Award: For leading the transition to the new MDR compliance and the commitment shown within the allocated projects. Show less

Aubonne, Canton Of Vaud, Switzerland

- Harmonization of a new marketed product creation - Define and clarify the code creation process for a FP, enabling core data on time in accordance with GxP guidelines and Regulatory information from the relevant authorities - Standardize pre-data collection workflows, maximizing data quality - Implementation of clear guidelines (SOP) to support FP code creation within Biopharma Division including detailed roles and responsibilities

London, United Kingdom

- Support medical staff and biomedical scientists in specimen dissection - Aptitude to prepare and retrieve clinical data for medical-review - Risk management of laboratory safety and personnel - Performing the driven tasks always adhering to the GLP

- Accurately dispensed medicines to patients, assuring the strict compliance to the treatment- Pharmaceutical advise and surveillance of physiological and biochemical parameters (blood pressure, cholesterol levels, etc)- Certify the accuracy of all prescriptions, products and care services supplied, to assure the reimbursement from the health authorities- Management of safety stocks increasing daily service level

• Curricular traineeship at the Hospital Pharmaceutical Department, completed within the last year of the university;• Capability to put skills learnt on the Master into practice through assisting in the dispensing of medicines;• Collection of prescriptions from wards, with supervision of the pharmacist, checking the requirements and accompanying the pharmacist on the delivery round through the different clinical services.• Used computerized systems for data entry of patient… Show more • Curricular traineeship at the Hospital Pharmaceutical Department, completed within the last year of the university;• Capability to put skills learnt on the Master into practice through assisting in the dispensing of medicines;• Collection of prescriptions from wards, with supervision of the pharmacist, checking the requirements and accompanying the pharmacist on the delivery round through the different clinical services.• Used computerized systems for data entry of patient details:• Learned the importance of confidentiality within a medical/hospital setting. Show less

Executive Master (Mas), Global Supply Chain Management

Certificate, Quality Controler Tq1

Master'S Degree, Pharmaceutical Science

Education record