Cardinal Health Regulatory Affairs Supervisor (6 month Contract) in Tullamore, Ireland

Job Title: Regulatory Affairs Supervisor (18 month Contract) – EMEA

Division: EMEA – RA

Location: Tullamore/Dublin

Reporting to: Senior Manager RA – EMEA

JOB FUNCTIONS

Leadership of key EMEA-RA Operational areas :

Post-Market Surveillance Operations for EMEA region

  • Prompt submission of Vigilance Reports
  • Collaboration with Business Unit, Service & Repair, Regional Commercial and other functions as required, to resolve Competent Authority Queries
  • Oversight of PR Product Holds, and active leadership in FSCA Planning, Execution, implementation and Close-Out
  • Authorized Representative Function
  • Interface with HPRA and other Competent Authorities on issues of compliance, documentation requests and regulatory queries and challenges
  • Application of key corporate and Patient-Recovery policies and procedures

Pre-Market Regulatory Operations:

Maintenance and surveillance of Manufacturer and Class I Registrations

Resolution of issues pertaining to provision of Certificates of Free Sale (COFSs) and related documentation to support market registrations.

In addition, the RA Manager EMEA will:

  • Coach/Mentor Associate RA Specialist;
  • Oversee Time and Attendance; holiday plans etc.
  • Submit Initial Vigilance Reports in absence of RA Specialist
  • Monitor and assess vigilance reporting decisions and response to Regulatory queries by pR teams
  • Produce regular and ad-hoc reports on throughput, timeliness of Vigilance Reports, and FSCA performance as required.
  • Ensure compliance with the Company’s Security, Health & Safety and Documentation-training policies and requirements.

SKILLS & COMPETENCIES REQUIRED

Requirements:

  • Fluency in the English Language.
  • Previous experience in management of direct reports
  • Ability to analyse data and information, and solve problems
  • Regulatory knowledge and experience of compliance with the Medical Device Directive (MDD); ability to interpret regulatory requirements and respond appropriately to Regulators and customers.
  • Good interpersonal skills; strength to uphold regulatory requirements with conviction.

EDUCATION

  • Degree/Diploma in a scientific, engineering or related discipline

EXPERIENCE

  • Minimum 3 years’ experience in a medical device regulatory role
  • Experience in Post Market Compliance

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.