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Senior Regulatory Affairs Specialist
Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. 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.
Role/Responsibilities
• Manage Technical Documentation
• Manage global regulatory impact assessments
• Manage updates to global regulatory procedures
• Provide Regulatory support for R&D projects, input and approval for new product introductions
• Apply technical solutions to problem solving and quality improvement projects
• Use technical writing skills to clearly describe technical information
• Review and assess 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
• Serve 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
• Work with Quality, Operations, Engineering and other internal groups to investigate and recommend solutions to address potential regulatory issues
• 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
• 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
Skills/Experience:
• Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
• Minimum of 3 year’s experience in R&D, QA/RA, Validations
• 3/4 year’s 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 in 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
• Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.
For further information contact James Cassidy james.cassidy@lifescience.ie or call in confidence 0860204322
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