Regulatory Affairs Associate
Our client is looking for a regulatory affairs associate who will deal with the compliance and approval of products. This person will also be responsible for determining and supporting regulatory activities.
Responsibilities
• Use technical solutions for problem solving
• Improve quality of projects
• Use strong writing skills to clearly define and describe technical information
• Analyse customer complaints
• Identify trends and corrective actions
• Review and assess of change control activities for potential impact on current regulatory filings
• Maintenance to ensure compliance of regulatory procedures are followed
• Adhere to established and evolving internal requirements
• Co-ordination and maintenance of global country labelling requirements.
• Support Regulatory inspections at the site as directed
• Liaise with other departments to ensure correct supporting data generated and provided in a timely manner
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives
Requirements
• Engineering/Science qualification with 2/3 years of working within R&D/QA/RA in a medical device environment.
• 2/3 years’ experience in R&D, QA/RA, Validations
• 2/3 years’ experience in Risk, Clinical and Biocompatibility
• Excellent technical writing experience within a medical device environment
• Attention to detail and accuracy
• Fluent English
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, primarily PowerPoint, Word, MD Project, Outlook and Excel
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously
• Ability to interface with all levels of management.
• Travel up to 30%
If you would like further Information you can contact the recruiter directly:
James Cassidy | Tel: +353 (0) 1 5079250
