Senior regulatory affairs specialist - united kingdom, reading, berkshire

the senior regulatory affairs specialist is to combine knowledge of scientific, regulatory and business issues to enable product development, manufacture and life cycle maintenance to meet applicable regulatory requirements and applicable technical standards. client details my client is a leading medical devices manufacturer, one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. description lead ra representative for design change assessment projects for active medical devices (pems), responsible for assessing regulatory impact of the change - determining testing needs/ documentation needs/ registration needs. lead and execute international product registrations attending to individual country specific requirements; monitor and report progress prepare and maintain regulatory files such as sted and mdd/mdr technical files; may participate in cross-functional product development teams as the regulatory representative; development of regulatory strategies may attend to audits performed by internal and external authorities to represent ra positions and processes; assesses changes in regulations and helps to determine their impact; prepare regulatory dossiers for submission to health authorities and maintains them along the whole product life-cycle. handle capas to implement corrective and preventive actions profile sound knowledge of the regulatory framework pertaining to medical devices such as the mdd/mdr ce marking; good working knowledge of design control, software life cycle, risk management, v&v processes; solid knowledge and material experience in international registrations/approval process for medical devices degree or equivalent in engineering or scientific discipline, or equivalent proven experience. job offer competitive package available


Michael Page
United Kingdom, Reading, Berkshire
2022-10-29
2022-11-28
FULL-TIME
2250384
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