![Ortho Clinical Diagnostics](https://media.trabajo.org/img/noimg.jpg)
Senior QRC Specialist Italy
1 settimana fa
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/notificationin 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, liason 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 liason 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.
«Le persone interessate possono inviare la propria candidatura con autorizzazione ai sensi del dlgs. 196/2003. La ricerca rispetta il d.lgs. 198/2006 ed è aperta a candidat* di qualsiasi orientamento o espressione di genere, orientamento sessuale, età, etnia e credo religioso. Il presente annuncio è stato ideato nel rispetto della diversity e dell’inclusività».
#LI-AM1
-
Italy Senior Tax Specialist
2 mesi fa
Milan, Italia Prysmian Group A tempo pienoTeam Overview and Job Responsibilities Within the Italy Tax Team , the Senior Tax Specialist will be part of the Italy Tax Department and will perform, supporting the Tax Manager, mainly the following activities with reference to the Italian Legal entities of the Group: Manage tax compliance activities related to CIT (tax computation, tax returns,...
-
Italy Senior Tax Specialist
4 settimane fa
Milan, Italia Prysmian Group A tempo pienoTeam Overview and Job Responsibilities Within the Italy Tax Team , the Senior Tax Specialist will be part of the Italy Tax Department and will perform, supporting the Tax Manager, mainly the following activities with reference to the Italian Legal entities of the Group: Manage tax compliance activities related to CIT (tax computation, tax returns,...
-
Italy Senior Tax Specialist
3 settimane fa
Milan, Italia Prysmian Group A tempo pienoTeam Overview and Job Responsibilities Within the Italy Tax Team , the Senior Tax Specialist will be part of the Italy Tax Department and will perform, supporting the Tax Manager, mainly the following activities with reference to the Italian Legal entities of the Group: Manage tax compliance activities related to CIT (tax computation, tax returns,...
-
GxP Country Quality Senior Specialist
4 settimane fa
Milan, Italia Alexion Pharmaceuticals A tempo pienoGxP Country Quality Senior Specialist (Italy) Reports to: Director, Italy Regulatory Affairs and Quality Location: Office-based, Milan, Italy Position Summary The GxP Country Quality Senior Specialist will be supporting the implementation, execution and management of the Corporate Quality System in Italy ensuring that the pharmaceutical operations...
-
GxP Country Quality Senior Specialist
3 settimane fa
Milan, Italia Alexion Pharmaceuticals A tempo pienoGxP Country Quality Senior Specialist (Italy) Reports to: Director, Italy Regulatory Affairs and Quality Location: Office-based, Milan, Italy Position Summary The GxP Country Quality Senior Specialist will be supporting the implementation, execution and management of the Corporate Quality System in Italy ensuring that the pharmaceutical operations...
-
Senior Compliance Specialist
1 mese fa
Milan, Italia BFF Banking Group A tempo pienoBFF Banking Group is the largest specialized finance operator in Italy and a leader in Europe in managing and securitizing non-performing commercial credits owed to Public Administrations. The Group is also a leader in Italy in Securities Services and banking payment services. Operating since 1985 and listed on the Italian Stock Exchange, BFF is experiencing...
-
Senior Sales Partner
1 mese fa
Milan, Italia Netflix A tempo pienoNetflix is one of the world's leading entertainment services, with over 260 million paid memberships in over 190 countries, enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywhere, and can change their plans at any time. With the incredible launch...
-
Senior Sales Partner
3 settimane fa
Milan, Italia Netflix A tempo pienoNetflix is one of the world's leading entertainment services, with over 260 million paid memberships in over 190 countries, enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywhere, and can change their plans at any time. With the incredible launch...
-
Senior Specialist
2 mesi fa
Milan, Italia LTIMindtree A tempo pienoSenior Specialist Job Req Id: 1275276 Role: SENIOR SALESFORCE DEVELOPER Location: Milan, Italy Mode Of Employment: Permanent Hybrid Work Model: YES (4 DAYS/WEEK) Local Language Proficiency: English Basic Responsibilities Build Salesforce solutions across multiple domains (declaratively and programmatically) Adhere to design and coding standards and best...
-
Senior Specialist
1 mese fa
Milan, Italia Alexion Pharmaceuticals A tempo pienoRegulatory Affairs Senior Specialist Reports to: Director, Italy Regulatory Affairs and Quality Location: Milan, Italy Position Summary The Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements...
-
Senior Specialist
3 settimane fa
Milan, Italia Alexion Pharmaceuticals A tempo pienoRegulatory Affairs Senior Specialist Reports to: Director, Italy Regulatory Affairs and Quality Location: Milan, Italy Position Summary The Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements...
-
Senior Finance Manager Italy
1 mese fa
Milan, Italia Ascendis Pharma AS A tempo pienoAre you passionate about ensuring financial integrity, implementing strategic financial initiatives, and providing actionable insights to drive business growth and profitability? Do you have experience within building bridge between a local affiliate and global finance? If so, now is your chance to join Ascendis Pharma Italy as our new Senior Finance Manager...
-
Milan, Italia Deloitte A tempo pienoWhat impact will you make? Experienced – Senior Events Specialist | Staff Interno - Deloitte Italy Stiamo cercando una figura Experienced da inserire nel team di Events del nostro Staff Interno di Brand and Communication nella sede di Milano, che lavorerà in modalità Hybrid. Sarai coinvolto nell'ideazione, realizzazione e verifica di eventi...
-
Talent Acquisition Specialist
2 mesi fa
Milan, Italia The Kraft Heinz Company A tempo pienoDescription We have an exciting opportunity for a driven Talent Acquisition Specialist taking care of our Italy business! The role is based in Milan and reports into the Head of People & Performance Italy with a dotted line to the Head of Talent Acquisition Europe and Pacific Developed Markets (EPDM). In this role, your main mission is the...
-
Talent Acquisition Specialist
3 settimane fa
Milan, Italia The Kraft Heinz Company A tempo pienoDescription We have an exciting opportunity for a driven Talent Acquisition Specialist taking care of our Italy business! The role is based in Milan and reports into the Head of People & Performance Italy with a dotted line to the Head of Talent Acquisition Europe and Pacific Developed Markets (EPDM). In this role, your main mission is the...
-
Senior Finance Manager Italy
1 mese fa
Milan, Italia Ascendis Pharma A tempo pienoAre you passionate about ensuring financial integrity, implementing strategic financial initiatives, and providing actionable insights to drive business growth and profitability?Do you have experience within building bridge between a local affiliate and global finance?If so, now is your chance to join Ascendis Pharma Italy as our new Senior Finance Manager...
-
Senior Finance Manager Italy
3 settimane fa
Milan, Italia Ascendis Pharma A tempo pienoAre you passionate about ensuring financial integrity, implementing strategic financial initiatives, and providing actionable insights to drive business growth and profitability?Do you have experience within building bridge between a local affiliate and global finance?If so, now is your chance to join Ascendis Pharma Italy as our new Senior Finance Manager...
-
Communication Specialist Italy
3 settimane fa
Milan, Italia Mondelēz International A tempo pienoDescription Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It Matter. You will execute communications activities including publishing, measurement coordination and other operational activities across internal and/or external channels. How you will contribute In this...
-
Communication Specialist Italy
3 settimane fa
Milan, Italia Mondelēz International A tempo pienoDescription Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It Matter. You will execute communications activities including publishing, measurement coordination and other operational activities across internal and/or external channels. How you will contribute In this role, you...
-
Senior IT BSS Specialist
1 mese fa
Milan, Italia Vodafone A tempo pienoRole purpose: The IT Senior BSS Specialist within the "VBI Sales channel" team plays a crucial role in the design, implementation, and optimization of IT systems supporting the sales processes for Enterprise segment products. The role demands technical expertise, leadership skills, and effective collaboration with both IT teams and Business stakeholders. Key...