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Job Details

Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location:
Reference: ND9522
Closing Date: 21 Oct 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

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

Requirements:

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 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 skills 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.

• 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

 

Qualifications/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 is essential

• 2/3 years’ experience in Risk, Clinical and Biocompatibility is an advantage

• Excellent technical writing experience within a medical device environment is essential

• 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%

If you are interested in applying for this role 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

Apply for this job: Regulatory Affairs Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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