Cardinal Health Regulatory Affairs Supervisor (6 month Contract) in Tullamore, Ireland
Job Title: Regulatory Affairs Supervisor (18 month Contract) – EMEA
Division: EMEA – RA
Reporting to: Senior Manager RA – EMEA
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
- 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.
- Degree/Diploma in a scientific, engineering or related discipline
- 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.