Cardinal Health Quality and Regulatory Affairs Specialist - France & Belgium in Paris, France

SUMMARY OF THE JOB:

  • Execute quality and regulatory processes within French & Belgium territory
  • 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 European level for countries under his/her area of responsibility
  • Act as Local Safety Officer for local authorities under his/her area of responsibility
  • Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in France & Belgium

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Execute quality processes :

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

  • Ensure all complaints related to Cordis/Cardinal Health products at the country level are reported to the Cordis Miami Department according the Cordis procedure and support communication to Authorities as necessary (ANSM in France, AFMPS in Belgium)
  • Act on Field Remedial Actions and FSCA communicated by Cordis /CAH according the company procedures at the country level
  • Execute stop-shipments/ Field Actions initiated by Cordis /CAH and ensure compliance with Cordis procedures at the country level
  • Coordinate documentation of the Quality Management System according company procedures
  • Support internal and external audits and inspections with the QRA Manager
  • Coordinate corrective and preventive actions

  • Execute regulatory processes:

  • Ensure regulatory compliance of Medical Products to international, regional 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 (SNITEM, CNEDIM,AFMPS), etc…

  • Fully responsible for implementing PRA for the countries under his/her scope and support PRA process as necessary for the region
  • Ensure coordination and consolidation of RA assessment notification for the region
  • Support the overall registration strategies, coordination, implementation, execution, control and completion of product registrations in France and Belgium

  • Copy Clearance: review and approve the content and translations of advertising material as per the France and Belgium standards & established process for the specific countries under his/her authority.

  • Ensure compliance with Environmental regulations
  • Engage in process excellence and improvement of procedures at the EMEA level
  • Support RA assessment of new, modified regulations for European/ countries under his/her scope to present outcomes and resolutions proposals for Cardinal Health
  • Provide regulatory support to the Sales and Marketing department, Tenders department, HCC 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
  • Contribute to Regulatory intelligence (involvement on internal and external working group, participation to meetings and congresses with the SNITEM ..)
  • Ensure regulatory and quality training and assessments for Sales & Marketing Department and for any other concerned employees and work closely with business department
  • Support record Retention appropriately

  • support business communication related issues or opportunities to next management level

  • Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Ensure 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 or Biological science or related field of study or related experience in the medical device industry; MS degree preferred
  • Five (5) to seven (7) years’ experience in the medical industry with at least three to five years in Regulatory Affairs of Medical Devices and/or Scientific formation +/-master in Regulatory Affairs or MD

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

  • Consistent background and knowledge of MD regulations in Europe and especially France and Belgium
  • Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, World Wide Regulatory Requirements/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
  • Ability to work in team and to share experiences
  • Good communications skills, including English and French fluency

ADDITIONAL POSITION REQUIREMENT :

  • Travel: 15% (regional offices)
  • Occasional weekend/travel work may be required as necessary

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.

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.