Senior Regulatory Compliance Specialist Italy

4 settimane fa

Milano, Lombardia, Italia Ortho Clinical Diagnostics A tempo pieno

The Opportunity

Ortho Clinical Diagnostics is a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. We are a team of over 6,000 strong, operating in over 130 countries, providing fast, accurate, and consistent testing where and when it's needed most – from home to hospital, lab to clinic.

Your New Role

You will be responsible for ensuring conformity of regulatory processes and strategies to local and international regulations as well as Ortho Clinical Diagnostics standards. You will contribute to the development and implementation of regulatory strategies for the company. In charge of managing communications with regulatory agencies, customers, and the Strasbourg Center of Excellence during the management of vigilance activities, product notifications, customer complaints, and customer communications. You will manage the 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. You will manage the Quality Management System in alignment with the EMEA Quality strategy, e.g., support of local Management Review, management of Corrective and Preventive Actions, and support of quality improvement projects. You will support 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. You will also support internal, external, and supplier audit programs as well as local Health Care Compliance and EHS activities. In charge of product registration/notification in the Italian Repository of the MoH (Repertorio Dispositivi Medici) and ensure to keep them under control and uploaded.

Key Responsibilities

  • 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 Ortho Clinical Diagnostics 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).

Requirements

  • 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.

Ortho Clinical Diagnostics is an equal opportunities employer and welcomes applications from all qualified candidates.

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