Cache of job #13872815

Job Title

Senior Regulatory Affairs Specialist

Employer

CPL

Location

Athlone, Westmeath

Description

JOB PURPOSE: The Sr. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. 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. Working with Quality, Operations, Engineering and other internal groups 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. 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. Serves as RA team member for promotional materials review, experimental designs, data analysis, risk. management and product labeling 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. ESSENTIAL SKILLS / 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 essential. 4/5 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 20% BEHAVIOURS / VALUES: Approachable and enthusiastic. Flexible and adaptable. Travel to Europe and Malaysia. Able to work on own initiative and as a team player. Good organizational skills with cultural awareness and sensitivity. This job originally appeared on RecruitIreland.com.

Date Added

2213 days ago

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