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Job Details

Senior Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location:
Reference: ND9556
Closing Date: 15 Mar 18
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

My client, a leading medical device company, currently have a new opportunity for a Senior Regulatory Affairs Specialist to join their team. This is a 2 year contract position based in the midlands of Ireland which will include travel to international sites.

Requirements:

The successful candidate will be involved with developing strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction.

Key responsibilities will include (but are not limited to) the following:

• Apply technical solutions to problem solving and quality improvement projects.

• Use technical writing skills to clearly describe technical information

• Working with other internal groups to investigate and recommend solutions to address potential regulatory issues

• Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.

• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks

• Analyse customer complaints, identify trends and execute corrective actions

• Review and assess of change control activities for potential impact on current regulatory filings.

• Ensure continual Quality System compliance

• Serve as RA team member for promotional materials review

• 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 4/5 years of working within R&D/QA/RA in a medical device environment.

• 4/5 years’ experience in R&D, QA/RA, Validations

• 4/5 years’ experience in Risk, Clinical and Biocompatibility would be an advantage

• Excellent technical writing experience within a medical device environment

• Fluent English, both written and oral

• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)

• 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 20%

 

To apply for this role please call Nicola on +353 1 2784671 or e-mail 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: Senior 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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