The Job holder directly manages the local RAQA Team and is accountable for RA, QA.
The job holder manages the RAQA Teams/function of the distribution business in the country through his supervision, ensures that such organizations continue to meet all RAQA requirements and Industry standards.
The job holder’s prime responsibility is to ensure that the businesses of the country placed under his supervision are run and built for sustainable long term commercial results around core ethics, regulatory and quality working practice
The job holder will stablish and mantain the relationship with local CA in everything related with the activities performed by RAQA dpt
The job holder will stablish and mantain the relationship with Industry associations (as Assobiomedica) activily participating
Whereas the mission of the selling organization in the country is to distribute products where both CE-marking and national regulatory schemes exist, the job holder will manage the team of local RA representatives to make sure that the products sold in the country will comply the above said regulations.As such, his/her main responsibilities are to :
• Liaise with the stakeholders in place in the country (local office, franchise marketing/ sales organization or local distributors) and make sure that existing regulatory requirements are known and controlled.
• Make sure that the national notification schemes exists are able to create and maintain a database in which all registrations made in the country is recorded and this database is able to proactively alert when such registrations needs to be renewed.
• Address and highlight the RA activities of his/her team in a monthly report sent at the end of each month to his/her direct responsible person.
• Make sure that the local organization operate in line with the Divisional QA System requirements. The job holder is directly accountable for the ISO Certification of this organization.
• Ensure that all organizations (direct selling, Rep-off offices,….) of the country operates with Divisional QA System requirements and continue to fit with the EMEA ISO Certification programme, Eu and local regulations
• Ensure awareness of customer requirements throughout the organization to consistently provide products and services that meet customer’s expectation.
• Organize and lead at fixed intervals, formal reviews of the Quality System of the local division to ensure and monitor its suitability, adequacy and effectiveness
• Keep the local team informed about the performances of the Quality management system, including the needs for improvement.
• Ensure that an adequate training program covering the developmental needs of the local organization is defined and implemented.
• Ensure that distributors/general Agencies in the country are regularly audited and do perform in line with Requirements
• Define and propose the budget necessary to implement, monitor and maintain the Quality Assurance system and the related RA and Vigilance activities
• Ensure that the local RAQA organization operates in line with the approved budget.
• Address and highlight the QA activities of his/her team in a monthly report sent at the end of each month to his/her direct responsible person.
• Ensure that Europe Post-Marketing Vigilance Procedures are properly implemented in the local site
• Ensure that products legacy data (products traceability) are consistently and safely maintained in the local site
• Be directly accountable for the control of the PMS activities in the country
• Address and highlight the PMS activities of his/her team in a monthly report sent at the end of each month to his/her direct responsible person.
As part of the EU organization will be responsible of a franchise at Eu level, providing support to the Business and interacting with design division in irder to support and facilitate any RAQA issue linked with the franchise.