The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
Your new role You will be responsible for ensuring conformity of regulatory processes and strategies to local and international regulations as well as QuidelOrtho standards; you will contribute to development and implementation of regulatory strategies of the company. In charge of the management of communications with regulatory agencies, customers and Strasbourg Center of Excellence during management of vigilance activities, product notifications, customer complaints and customer communications. You will manage roll-out of field safety corrective actions and field actions in collaboration with global Quality, Regulatory & Compliance functions as well as the product representative/manufacturer; management of the Quality Management System in alignment with the EMEA Quality strategy, e.g. support of local Management Review, management of Corrective and Preventive Actions as well as support of quality improvement projects. You will be supporting commercial processes, including review and approval of promotional material, QRC support for product lifecycle management and provision of quality and regulatory input to tenders and customer contracts; supporting also internal, external and supplier audit program as well as local Health Care Compliance and EHS activities. In charge of the product registration/notification in the Italian Repository of the MoH (Repertorio Dispositivi Medici) and ensure to keep them under control and uploaded.
What you'll be doing Support commercial business through support of Product Lifecycle, completion and maintenance of tender submissions and customer contracts as well as completion of Copy-Review approval of Promotional Material.Roll-out of Field Actions as well as global Customer Communications to authorities and customers, including management of translation of documents into local language. Follow-up on vigilance cases.Monitor regulatory requirements and ensure conformity to those. Perform Post-Market Surveillance activities. Complete impact assessment to global Change Control process and complete Product Notifications for new and changed products.Act as contact person, liaison with local health representative and represent QuidelOrtho in local regulatory associations. Appointment and delegation to allow the signature of the uploading of the regulatory file in the Italian Repository of the MoH (Repertorio Dispositivi Medici) on behalf of Ortho Italy Legal Representative.Management and improvement of the Quality Management System in alignment with the EMEA Quality strategy, e.g. conduct Management Reviews, write / maintain quality system documentation and procedures, management of Corrective and Preventive Actions, support global and local Training Program, sponsorship of quality improvement projects. Preparation and performing of internal & supplier audit (certified auditor according ISO 19011). Support external audits. Support Supplier and Distributor control program.Support customer complaint system on local level (e.g. written close-out to customers, iCOM system). Answer to customers quality requests in liaison with Hotline.Compliance: Support of EMEA Health Care Compliance, Privacy and Transparency reporting on interactions with HCPs/HCOs. Support local environmental product legislation compliance & safety requirements (e.g. REACH, RoHS; Declaration to local ecobody Waste Electrical and Electronic Equipment (WEEE) and others).What you'll need to succeed Technical degree, or diploma in chemistry, biochemistry, biology, pharmacy, engineering or related.3-5 years of previous experience in a similar position in a regulated industry (Medical Device, IVD or drugs).Independent working ability.Strong communication skills.Strong knowledge of Italy regulations and local compliance, used to interact with local authorities (Ministero della Salute).Good knowledge of the IVD Medical Device regulatory environment.Experience in managing Quality Systems (ISO 9001-ISO13485 standards).Fluent in English (oral and written) and Italian.
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