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Cardinal Health

QRA and Clinical Director EMEA

Cardinal Health - Dublin, GA

At Cardinal Health, we are developing the innovative products and services that make healthcare safer and more productive. This is your opportunity to join a growing, global company genuinely committed to making a difference to our customers and communities.Summary of the Role:Responsible for strategic oversight and leadership direction within the QRA and Clinical functions in EMEAEffectively overseeing functions of the QRA and Clinical staff in EMEASupport quality, regulatory and Clinical processes in EMEAGuarantee that regulatory requirements are met in regards to local and national laws and company standards in order to place and/or maintain products on the marketsAct as Management Representative for local authorities and organizationDevelop and implement quality, regulatory, clinical strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in countryRepresent Cardinal Health in trade associations and external organizationsEssential Duties and Responsibilities:Act as Management Representative for local authorities, for the Quality Management System and the organizationLead and ensure execution and compliance with quality processes in EMEA:Support and Supervise the complaints processes in the region as well as provide appropriate support for communication and follow-up with authorities and usersAct on Field Remedial Actions, Field Safety Corrective Actions, stop shipments communicated by Cordis Corporation according the Cordis Corporation proceduresManage documentation of the Quality Management System according the Cordis Corporation proceduresSupport the EMEA staff for internal and external audits and inspectionsSupport the EMEA staff for supervision of distributors, LSP’s and third partiesSupport corrective and preventive actions execution as necessaryResponsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good conditionLead and ensure execution and compliance with regulatory processes in EMEA:Ensure regulatory compliance of Medical Products to national, regional and international laws and company standards in order to place and/or maintain products on the markets: PRA, life cycle management, and notification to national competent authorities, copy clearances.Provide regulatory support of the team to the Sales and Marketing department, Tenders department, HCC Department as necessaryProvide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globallyInstill and drive a regulatory culture. Establish and support policies and standards as well as ensure active representation in trade association and external environment to support Regulatory IntelligenceLead and ensure execution and compliance with Clinical processes in EMEA :Ensure Clinical Studies and Registries application to the Ministry of Health as appropriateEnsure duly reporting of SAE’s and device deficiencies in alignment with regulationSupport the global Clinical team in communication with EMEA InvestigatorsProvide continuing Clinical expertise for supporting clinical evidence strategy and clinical evaluation documentation for companies productsEnsure processes excellence for a compliant and sustainable organization in EMEAResponsible for strategic oversight and leadership direction within the QRA and Clinical functionsComply with Cardinal Health PoliciesManage subordinate staffEducation/Training and/or Experience:Bachelor’s Degree in Nursing, Engineering, Physical or Biological science or related field of study; MS degree preferredMinimum of 10’ years’ experience in Quality or Regulatory or Clinical Affairs of Medical DevicesScientific formation /-master in Regulatory Affairs or MDRequired Knowledge, Skills, Abilitiesand Certifications/Licenses:Consistent background and knowledge of MD regulationsProven expertise in all aspects of QRA and Clinical AffairsLeadership and management skillsIndependency, problem solving and ability to drive initiatives by his/her ownRelations established with the key interlocutors in the network of the MDs (e.g., regulatory agencies, professional organizations, etc.)Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plansTeam spiritInternational experienceGood communications skills, including EnglishAdditional Position RequirementsTravel: 25% (predominantly to US HQ’s and regional/ national offices)Occasional weekend/travel work may be required as necessaryPosted TodayFull time20024732

9 days 21 hours ago

Cardinal Health

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QRA and Clinical Director EMEA Cardinal Health - Dublin, GA, United States

   

Location: Dublin, GA

Company Profile:
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality.