QRA and Clinical Director EMEA

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 EMEA

  • Effectively overseeing functions of the QRA and Clinical staff in EMEA

  • Support quality, regulatory and Clinical processes in EMEA

  • Guarantee 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 markets

  • Act as Management Representative for local authorities and organization

  • Develop and implement quality, regulatory, clinical strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in country

  • Represent Cardinal Health in trade associations and external organizations

Essential Duties and Responsibilities:

  • Act as Management Representative for local authorities, for the Quality Management System and the organization

Lead 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 users
  • Act on Field Remedial Actions, Field Safety Corrective Actions, stop shipments communicated by Cordis Corporation according the Cordis Corporation procedures
  • Manage documentation of the Quality Management System according the Cordis Corporation procedures
  • Support the EMEA staff for internal and external audits and inspections
  • Support the EMEA staff for supervision of distributors, LSP’s and third parties
  • Support corrective and preventive actions execution as necessary
  • Responsible 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 condition

Lead 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 necessary
  • Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally
  • Instill 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 Intelligence

Lead and ensure execution and compliance with Clinical processes in EMEA :

  • Ensure Clinical Studies and Registries application to the Ministry of Health as appropriate
  • Ensure duly reporting of SAE’s and device deficiencies in alignment with regulation
  • Support the global Clinical team in communication with EMEA Investigators
  • Provide continuing Clinical expertise for supporting clinical evidence strategy and clinical evaluation documentation for companies products
  • Ensure processes excellence for a compliant and sustainable organization in EMEA
  • Responsible for strategic oversight and leadership direction within the QRA and Clinical functions
  • Comply with Cardinal Health Policies
  • Manage subordinate staff

Education/Training and/or Experience:

  • Bachelor’s Degree in Nursing, Engineering, Physical or Biological science or related field of study; MS degree preferred
  • Minimum of 10’ years’ experience in Quality or Regulatory or Clinical Affairs of Medical Devices
  • Scientific formation +/-master in Regulatory Affairs or MD

Required Knowledge, Skills, Abilitiesand Certifications/Licenses:

  • Consistent background and knowledge of MD regulations
  • Proven expertise in all aspects of QRA and Clinical Affairs
  • Leadership and management skills
  • Independency, problem solving and ability to drive initiatives by his/her own
  • Relations 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 plans
  • Team spirit
  • International experience
  • Good communications skills, including English

Additional Position Requirements

  • Travel: 25% (predominantly to US HQ’s and regional/ national offices)
  • Occasional weekend/travel work may be required as necessary