Save Job Back to Search Job Description Summary Similar Jobs Added 27/08/2024great opportunity to join well developed businessstable position and high profile organisational cultureAbout Our ClientOur client is an international company noting a constant growth in its sector in the manufacturing market.Job DescriptionProvide support and guidance to analyze, design and develop regulatory files on various products and projects.Maintain on-going understanding and knowledge of the latest regulatory requirements in compliance with worldwide regulations and guidance documents. Key focus on European and US regulations.Review, preparation and implementation of regulatory SOPs, in line with both the applicable market requirements and best Group practices.Review regulatory documentation from key resources e.g. customers/projects, products etc. to ensure that customer and company requirements are met.Compilation/support the creation, of regulatory files, for key customers, products and projects.Provide input, at key project/design phases; e.g. pre-sales support, concept/design kick off, project/design review and final project/design transfer to production, to ensure that all regulatory requirements are 'in compliance'.Support validation activities, as necessary, to comply with defined regulatory regulations, global/local procedures and customer requirements.internal and external audits and any associated regulatory/quality assurance programs.Support, co-ordinate/conduct training in Regulatory procedures, as required.Support to the Quality Assurance Department for key operational activities e.g.;non-conformances/complaint reporting, where a regulatory issue is identified;specification approval,remotely support supporting internal and external audits based on approved schedule,update and correction of QMS documents and records archive (related to regulatory).The Successful ApplicantBachelor's or advanced degree in engineering or a related major scientific disciplineMinimum 3 years of experience in regulatory activities and associated requirementsExperience within the regulatory industries associated with 21CFR820, ISO 13485, European regulations MDR, EUDAMEDPrevious experience in FDA and ISO regulated industriesExperience in direct communication with Notified Bodies and Regulatory AgenciesAbility to work independently or as part of a team to complete projects within required timeframesHighly proficient in spoken and written EnglishWhat's on OfferAbility to work in international environment both within internal organizational structure and customers (100% from Western Europe)Dynamic and fast growing culture companyContinuous learning environmentOpportunity for career progression dependent on achievementsContactSara BielskaQuote job refJN-082024-6517200Job summarySectorEngineering & ManufacturingSub SectorQualityIndustryIndustrial / ManufacturingLocationJelcz-LaskowiceContract TypePermanentConsultant nameSara BielskaJob ReferenceJN-082024-6517200