Job Description
Our Client, a major multinational, distributes durable and non-durable goods in healthcare/medical sector.
For the Italian Headquarters, located southwest of Milan, we are seeking a
Quality & Regulatory (QARA) Specialis
ACTIVITIES
Reporting directly to the Quality & Regulatory Manager, the specialist will manage activities related to the area Quality Assurance and Regulatory Affairs for Italy
MAIN DUTIES AND RESPONSIBILITIES
Quality Systems
Maintaining and improving the quality management system preparing and updating procedures, work instructions, forms, processes, quality handbook and other relevant documentation
Manage processes for effective and compliant management of adverse events, product complaints, recalls:
Providing support to the Safety Officer for the review and determination of the reportability of adverse events
Raising and issuing Adverse Event Reports to the Competent Authority where determined reportable
Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements.
To manage the CAPA process ensuring CAPAs are documented and completed in a timely manner. Ensuring effectiveness of actions taken by completing follow up audits where deemed necessary.
Coordination of recalls/withdrawals/field safety notifications from suppliers and corporate regulatory
Perform GDP and Quality /regulatory related trainings
Support in carrying out internal and external audits, following up non conformities and related corrective actions and eventual observations and improvement proposals
Support QARA Manager in granting conformity to national and international laws and regulations even in cooperation with international regulatory teams
Support QARA Manager in all activities related to maintenance of ISO certification, pharma licenses and compliance to international and national laws and interaction with health authorities and notified bodies
Responsible to ensure corrective preventive measure is followed up and closed on a timely manner
Support and guidance to customer verification
Define processes for technical service in accordance to hygiene and ISO 13485 reuqirements.
Regulatory Affairs
Contribute to the process of medical device registration in the authority data base through acquisition, validation and preparation of documentation necessary for the registration
Provide regulatory support to departments involved in imports
Provide regulatory support in the product launch and validation of conformity documentation and registration of products
MDR compliance IFU, CE and labelling checks and support to implement all applicable procedures according Article 13 and Article 14 MDR
Performing and assisting with coordination of rework activities
GDP RP
(if possible based on qualification: Act as Pharma Responsible Persons or deputy RP and ensure GDP compliance of the quality management system in the warehouse, temperature monitoring, deviation management, transport verification and support and host inspections to maintain pharma licenses.
Fulfill all tasks defined according to GDP Article 2.2.
REQUIRED QUALIFICATIONS
WORK EXPERIENCE: experience in similar roles, for at least two years, within the medical device industry and (or pharmaceutical company and passion for the healthcare industry
EDUCATION: technical/scientific or similar degree
KNOWLEDGE: ISO standards (9001 and 13485) and MDR regulation and preferably qualified auditor, preferably GDP knowledge and qualification as responsible pharmacist
English comfortable working knowledge
For the Italian Headquarters, located southwest of Milan, we are seeking a
Quality & Regulatory (QARA) Specialis
ACTIVITIES
Reporting directly to the Quality & Regulatory Manager, the specialist will manage activities related to the area Quality Assurance and Regulatory Affairs for Italy
MAIN DUTIES AND RESPONSIBILITIES
Quality Systems
Maintaining and improving the quality management system preparing and updating procedures, work instructions, forms, processes, quality handbook and other relevant documentation
Manage processes for effective and compliant management of adverse events, product complaints, recalls:
Providing support to the Safety Officer for the review and determination of the reportability of adverse events
Raising and issuing Adverse Event Reports to the Competent Authority where determined reportable
Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements.
To manage the CAPA process ensuring CAPAs are documented and completed in a timely manner. Ensuring effectiveness of actions taken by completing follow up audits where deemed necessary.
Coordination of recalls/withdrawals/field safety notifications from suppliers and corporate regulatory
Perform GDP and Quality /regulatory related trainings
Support in carrying out internal and external audits, following up non conformities and related corrective actions and eventual observations and improvement proposals
Support QARA Manager in granting conformity to national and international laws and regulations even in cooperation with international regulatory teams
Support QARA Manager in all activities related to maintenance of ISO certification, pharma licenses and compliance to international and national laws and interaction with health authorities and notified bodies
Responsible to ensure corrective preventive measure is followed up and closed on a timely manner
Support and guidance to customer verification
Define processes for technical service in accordance to hygiene and ISO 13485 reuqirements.
Regulatory Affairs
Contribute to the process of medical device registration in the authority data base through acquisition, validation and preparation of documentation necessary for the registration
Provide regulatory support to departments involved in imports
Provide regulatory support in the product launch and validation of conformity documentation and registration of products
MDR compliance IFU, CE and labelling checks and support to implement all applicable procedures according Article 13 and Article 14 MDR
Performing and assisting with coordination of rework activities
GDP RP
(if possible based on qualification: Act as Pharma Responsible Persons or deputy RP and ensure GDP compliance of the quality management system in the warehouse, temperature monitoring, deviation management, transport verification and support and host inspections to maintain pharma licenses.
Fulfill all tasks defined according to GDP Article 2.2.
REQUIRED QUALIFICATIONS
WORK EXPERIENCE: experience in similar roles, for at least two years, within the medical device industry and (or pharmaceutical company and passion for the healthcare industry
EDUCATION: technical/scientific or similar degree
KNOWLEDGE: ISO standards (9001 and 13485) and MDR regulation and preferably qualified auditor, preferably GDP knowledge and qualification as responsible pharmacist
English comfortable working knowledge
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