Àngels Roma Email & Phone Number

Barcelona, Ct, Es

Barcelona, Cataluña, España

Direct responsibility for product registrations world-wide, keeping company up to date on changes / developments in regulations. Works with customers directly to define regulatory strategy for new products. Works closely with R&D to provide Quality oversight of product design, development and introduction of new products.

Direct responsibility for registrations world wide, keeping company up to date on country regulations. Management of the complaints, vigilance system and post market surveillance activities. Direct management responsibility for managers and technicians from RA & MS dept.Main activities:• Supervise that all activities in RA & MS dept. are performed according to defined procedures and in case of deviations, ensure that any deviations are dealt with through the Quality System.• Obtain and keep updated all registration activities of Biokit and its products wherever and whenever required.• Responsible for the technical files needed to market all new products developed at Biokit R&D, OEMs products and customers’ products.• Responsible for complaints management.• Responsible for the notification to customers and Competent Authorities of any irregularities in the company’s products.• Responsible for Post Market Surveillance process.• Responsible for reporting metrics of RA & MS dept to VP Quality Assurance & Regulatory Affairs and CEO.• Participation in audits from Agencies and Customers.

- Create department focusing on Complaints Management.- Redefine the process of dealing with complaints.- Implement the use of a new tool: SAP Complaints Module.- Reduce the average time response to customer complaints.- Lead a team of 2 people.

- CE Mark and FDA registration responsible. - Project management of the products manufactured for one of the main clients: launch and registration of new products, products support, complaints and CAPA investigations.

Work in different projects in the Financial Services department. Main tasks:- Define requirements with the final user.- Analyze business gaps.- Design solutions for new requirements.

- Implement a safety methodology for the risk assessment.

Mba, Business Administration And Management, General

Study tour in Babson College, Boston. (April 2011)

Engineering, Chemical By Iqs

End of studies project: Methodology for the hazard assessment of chemical processes in Chemical companies.

Engineering, Chemical

Activities and Societies: AIQS Institut Químic de Sarrià