Regulatory Affairs Specialist

Summary
Our client is a large Medical Device organisation based in Athlone. They wish to recruit a Regulatory Affairs Specialist who will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for medical products globally

Key responsibilites
• Apply technical solutions to problem solving
• Apply technical solutions to quality improvement projects
• Use technical writing skills to clearly describe technical information
• Analyze customer complaints, identify trends and execute corrective actions
• Review and assess of change control activities for potential impact on current regulatory filings.
• Maintenance of Regulatory procedures to ensure continued compliance.
• Ensure continual Quality System compliance by adherence to established and evolving internal requirements.
• Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices.
• 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

Essential skills / experience
• 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 – essential
• 2/3 years experience in Risk, Clinical and Biocompatibility – an advantage
• Excellent technical writing experience within a medical device environment - essential • Attention to detail and accuracy – essential
• Fluent English, both written and oral – essential
• 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, including MS-Office (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; and the ability to interface with all levels of management.
• Travel up to 10%

Behaviours / values:
Approachable and enthusiastic .Flexible and adaptable. Travel to Europe and Malaysia Able to work on own initiative and as a team player. Good organizational skills with cultural awareness and sensitivity Good judgment and problem solving ability & is capable of understanding the impact of decision making on both the company and their customers.

Key relationships / interfaces:
• VP of QA/RA
• Director of QE/RA
• International QA/RA
• International Operations
• International R&D
• EMEA HQ Support functions
• Global QA/RA



Clodagh Nerney | Tel: +353 (0) 1 507 9254





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