Cache of job #13905226

Job Title

Regulatory Affairs Associate

Employer

CPL

Location

Westmeath

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 skills 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. 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. ESSENTIAL SKILLS / 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 essential. 2/3 years experience in Risk, Clinical and Biocompatibility an advantage. Excellent technical writing experience within a medical device environment - essential. Attention to detail and accuracy essential. Fluent English, both written and oral - essential. Ability to work well under deadlines and pressure. Problem solving skills for developing creative solutions and meeting objectives are required. Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel); Excellent analytical ability. 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 30% For full details email your CV to ndunphy@thornshaw.com or call Nicola on +353 1 2784671. For a full list of vacancies log on to www.thornshaw.com. This job originally appeared on RecruitIreland.com.

Date Added

2121 days ago

Apply