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June 22 2018

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Job Offer: Regulatory Affairs Associate:

Job description:

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Regulatory Affairs Associate

function Description


My client, a global medical devices company have a new opportunity for a Regultory Affairs Associate.

JOB PURPOSE:
The Regulatory Affairs Associate is responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for products globally
KEY RESPONSIBILITES:
Key responsibilities will include (but are not limited to) the following:
Apply technical solutions to problem solving
Apply technical solutions to quality improvement projects
Use technical writing expertise 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.
Co-ordination and maintenance of global country labelling requirements.
Support Regulatory inspections at the site as directed.
contact 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 conformity with significant guidelines and directives
ESSENTIAL expertise / practice
Engineering/Science qualification with 2/3 years of working within R&D/QA/RA in a medical device environment.
2/3 years practice in R&D, QA/RA, Validations essential
2/3 years practice in Risk, Clinical and Biocompatibility an advantage
Excellent technical writing practice within a medical device environment - essential
Attention to detail and accuracy essential
Fluent English, both written and oral - essential
capability to work well under deadlines and pressure
Problem solving expertise for developing creative solutions and meeting objectives are required.
expertise that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
Excellent analytical capability
The capability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the capability to interface with all levels of management.
Travel up to 30%

For further details send your curriculum Curriculum for ndunphy@thornshaw.com or call Nicola on +353 1 2784671
For a full list of vacancies log on to www.thornshaw.com

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Westmeath
Company Type Employer
Post Date: 06/14/2018 / Viewed 11 times
Contact Information
Company:
Contact Email: ndunphy@thornshaw.com


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