PHARMACEUTICAL JOBS
Regulatory Affairs Officer Dublin North
REGULATORY AFFAIRS OFFICER REQUIRED FOR OUR CLIENT IN THE PHARMA SECTOR.
The successful candidate will be working in an environment with an international outlook
Responsibilities:
- To ensure compliance with IVD, MDD and Food Supplement directives and other regulatory requirements
- To assist in any area of regulatory affairs at local or corporate level
- Review and Update of technical files and dossier
- Apprise company of developments in national and EU regulations and legislation
- Coordinate complaint investigations, follow up corrective actions, respond to complainant and prepare periodic summary reports.
- Assist with CE marking of products
- Coordinate audit programme and carry out internal and external audits
- Ensure product registrations are current and compliant
- Initiate corrections to Master Documents and Procedures as required
- Communicate with local and international regulatory authorities regarding licence applications, vigilance and compliance issues
- Liaise with and provide support to local companies on regulatory and quality issues
- Collect data and write reports for projects/assignments as indicated by the MT/RA Manager
- Maintain ISO 9001 and 13485 Quality System
- Assist in resolutions of quality issues that arise at sub contractor level
- Approve regulatory aspects of artwork
- Assess sub contractors to ensure they comply with release requirements
- Collect post market surveillance information
Person Profile
- Regulatory Experience within a Medical Device environment
- Minimum of a Scientific Degree
- Excellent interpersonal and communications skills.
- Ability to lead and support several concurrent projects/products and develop strong relationship within cross-functional teams.
- Excellent verbal and written skills.
- Strong team skills.
- Excellent computer skills including Advanced Excel, PowerPoint, and Project
- Willing to work in a result based environment, with minimal supervision.
- Execution – persistent drive for results utilizing sound project focus, organizational and problem solving skills.
- Ability to work independently and on one's own initiative
- Enthusiasm and Drive to take complete ownership and drive process improvement initiatives.
Location: Dublin 11
Status: Permanent
Salary: 40K + negotiable + benefits
If you have the necessary qualifications and experience please send your CV in the first instance. All applications will be treated in the strictest of confidence.
Job Added: 2011-04-20 13:20:00
Consultant: Frank Shortle