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June 19 2018

    Job details

Job Opportunity: REGULATORY AFFAIRS SPECIALIST:CPL

Job description:


   » Job ID.:15352927
   » Employer ID.:RI/JO-1805-408422_12
   » Published:24-MAY-2018
   » income:NEGOTIABLE
   » Job location:WESTMEATH
   » Employment Type:PERMANENT

 

My client, a leading medical device company, currently have a new permanent opportunity for a Regulatory Affairs Specialist.

The Regulatory Affairs Specialist is responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for Medical products globally.

Key responsibilities include:
• Apply technical solutions to problem solving
• Apply technical solutions to quality improvement projects
• Use technical writing expertise to clearly describe technical information
• Analyse 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 labelling as they relate to registration and commercialization of medical devices.
• 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

practice and Appropriate qualifications:
   » Engineering/Science qualification with 2+ years of working within R&D/QA/RA in a medical device environment.
   » 2/3 years’ practice in R&D, QA/RA, Validations is essential
   » 2/3 years’ practice in Risk, Clinical and Biocompatibility is an advantage
   » Excellent technical writing practice within a medical device environment is essential
   » 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 10%  
If you are interested in applying for this function please call Nicola on +353 1 2784671 or email ndunphy@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

This job originally appeared on RecruitIreland.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: 05/24/2018 / Viewed 41 times
Contact Information
Company: CPL
Contact Email: ndunphy@thornshaw.com


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