Cardinal Health Quality and Regulatory Affairs Specialist CEE in Warsaw, Poland

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We are currently looking to recruit a QRA Specialist Central and Eastern Europe (CEE). Based in ourwarsaw office in Poland and reporting to the Manager QRA CEE you will be responsible for the following:

The Role

  • Execute quality and regulatory processes at CEE level
  • Guarantee that regulatory requirements are met in regards to local and national laws and company standards in order to place and/or maintain products at the CEE level
  • Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in country
  • Support the Quality and Regulatory Affairs Manager CEE

Essential Duties and Responsibilities

  • Execute quality processes :

  • Ensure compliance of the CAH legal entity Quality Management System and of ISO certification as applicable

  • Support documentation of the Quality Management System according to the Cordis Corporation and CAH procedures
  • Support internal and external audits and inspections as necessary
  • Support corrective and preventive actions as necessary
  • Execute regulatory processes:

  • Ensure regulatory compliance of Medical Devices with European and national laws and company standards in order to place and/or maintain products on the markets: life cycle management, notification and communication to national competent authorities, etc…

  • Responsible for the overall registration strategies, coordination, implementation, execution, control and completion of product registrations at the CEE level
  • Support and advice the assessment project tasks relevant to regulatory affairs from product inception to product launch and post-market survey
  • Support product release processes as necessary
  • Ensure coordination and consolidation of RA assessment notification/ registrations for the region
  • Support the QRA manager for the review and approval of the content of advertising material for the region as per processes
  • Engage in process excellence and improvement of procedures at the CEE level
  • Support RA assessment of new, modified regulations for European/ countries under his/her scope to present outcomes and resolutions proposals
  • Provide regulatory support to the Sales and Marketing department, Tenders department, Legal and Compliance department, Clinical Education and Training department, …
  • Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally to support education of local regulations
  • Instill and drive a regulatory culture. Establish and support policies and standards for the measurement of new products
  • Ensure regulatory and quality training and assessments for Sales & Marketing Department and for any other concerned employees
  • Clinical Studies application as necessary
  • Responsible for communicating business related issues or opportunities to next management level
  • For employees with supervisory responsibilities, ensure that 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
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
  • Performs other duties assigned as needed

Education/Training and/or Experience:

  • Bachelor’s Degree in Nursing, Engineering, Physical, Biological or natural science or related field of study or related experience in the medical device industry; MS degree preferred
  • Two (2) to Five (5) years’ experience in the medical devices industry with experience in Regulatory Affairs of Medical Devices and/or Scientific formation

Required Knowledge, Skills, Abilities and Certifications/Licenses:

  • Consistent background and knowledge of MD regulations
  • Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, World Wide RegulatoryRequirements/Procedures,Project Management, and Negotiations
  • 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, in agreement with the Quality Assurance and Regulatory Affairs Director
  • Ability to work in team and to share experiences
  • Good communications skills, including English
  • A CEE language would be a plus.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.