Senior Manager Quality, Regulatory and Compliance EMEA

Senior Manager Quality, Regulatory and Compliance EMEA

Ortho Clinical Diagnostics

Milan, Brussels, Strasbourg or Pencoed

Responsibilities:

  • Ensuring conformity of regulatory processes and strategies to local and international regulations as well as Ortho standards;
  • Development and implementation of regulatory strategies of the company;
  • Development and management of communications with regulatory agencies, customers, European Support Center and distributors during management of vigilance activities, product notifications, customer complaints and customer communications;
  • Oversight of roll-out of field safety corrective actions and field actions across various countries in region, in collaboration with global Quality, Regulatory & Compliance functions as well as the product representative/manufacturer;
  • Management and improvement of the Quality Management System in alignment with the Ortho Worldwide Quality strategy, e.g. conduct Management Reviews, management of Corrective and Preventive Actions, internal audit program as well as identification and sponsorship of quality improvement projects;
  • Independent support of 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;
  • Active support of external and supplier audit program as well as local Health Care Compliance and EHS activities;
  • Position plays a pivotal role in managing risk and deciding on the most appropriate means to address issues for the best interests of the customer and the business;
  • Member of European Leadership Team, and executes responsibility for EU Authorized Representative (per Article 11);
  • 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 in regulatory associations;
  • Management and improvement of the Quality Management System in alignment with the Ortho worldwide 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, manage internal audit program as well as identification and sponsorship of quality improvement projects;
  • 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;
  • Conduct Audits (internal & supplier). Support external audits. Support Supplier and Distributor control program;
  • Lead group in EMEA QRC for various target markets within in EMEA region.

Profile:

  • Technical degree, diploma or PhD in chemistry, biochemistry, biology, pharmacy, engineering or related;
  • Certificate in Quality Management or Regulatory Affairs preferred;
  • At least 10 years of experience in regulated industry (Medical Device, IVD or drugs);
  • Advanced knowledge of global regulatory and quality system requirements (e. g. IVDD, ISO Standards, Risk Management, Quality System Standards);
  • At least 5 years of leadership experience;
  • Advanced communication and organization skills;
  • Business-fluent language skills in English. Advanced knowledge of other European languages desired;
  • Customer focus and strong collaboration principles.

Role should be ideally based in France - Strasbourg, Italy - Milan, Pencoed - UK or Belgium - Brussels.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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