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June 24 2018

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Job Opportunity: Regulatory Affairs Associate:Life Science Recruitment

Job description:

Regulatory Affairs Associate

Life Science Recruitment


   » Westmeath
   » Not disclosed
   » Permanent full-time
   » Updated 14/06/2018
   » James Cassidy this job is expired SaveSave Apply Now

Job detail


Our client is seeking a regulatory affairs associate who will deal with the compliance and approval of products.
 

Regulatory Affairs Associate
Our client is seeking 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 expertise 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
• 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

Requirements
• 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
• 2/3 years' practice in Risk, Clinical and Biocompatibility
• Excellent technical writing practice within a medical device environment
• Attention to detail and accuracy
• Fluent English
• 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, 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
• capability to interface with all levels of management.
• Travel up to 30%

If you would like more information you can contact the recruiter directly:

James Cassidy | Tel: +353 (0) 1 5079250

PLEASE APPLY DIRECTLY BY CLICKING HERE

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Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.

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Ref: ACDQ-760123
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Life Science Recruitment


   »  


   » 12 Fitzwilliam Square, Dublin 2
   » 01 685 45 45
   » applications@lifescience.ie
   » http://www.lifescience.ie



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 18 times
Contact Information
Company: Life Science Recruitment
Contact Email: applications@lifescience.ie


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