




**Detalles de la oferta** ------------------------- This exciting role is for independent contractors with significant experience in the RA/QA aspects of the life science industry sub\-sectors such as medical devices, in vitro diagnostics, lab\-developed tests, pharmaceuticals, and cosmetics.You will likely be an expert in regulatory affairs, helpingdesigners, manufacturers and distributors of medical devices and IVDs navigate the filing requirements for multiple countries in Latin America and the US, including cross\-border sample processing and reporting.We seek consultants, auditors, instructors, and those who have expertise and a passion for patient safety and population health improvement. We have good rates of compensation, defined by the project, and a top\-rated team to work alongside you.The roles are home\-based and require the ability to travel to Buenos Aires to theclient site on occasion. We therefore seek highly organized individuals who are self\-starters, good communicators and are open to flexible work arrangements, seeking variety in the work they do.You would be responsible for planning and delivering Life Science consulting engagements related to regulatory affairs strategy andinfrastructure, appropriate to the level of risk in a target product.Person DescriptionA confident personality and competent in getting ideas across to others effectivelyDemonstrates the ability to work in a team environment, especially when operating remotelyHas a passion for patient safety through effective regulatory and quality activitiesRespects the contribution of all colleagues and facilitates consensus on tough issuesDemonstrates flexibility in day\-to\-day working in the team and approach to unique client issuesAn ability to fit in with client culture and get ideas across effectivelyEstablished as an independent contractor or contract\-for\-hireEssential Base QualificationsBachelor's degree in Engineering, Science, or Life Sciences related fieldA minimum of ten years experience in life science, preferably multi\-country workEvidence of leading activities in their field (such as writing regulatory submissions)Significant experience in RA/QA matters related to any of: medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.Essential Industry RequirementsExperience with regulations across multiple countries in Latin AmericaExperience with establishing a regulatory strategy that aligns with business goals and appropriate risksExperience with strategy, submissions, clinical evaluation, post\-market surveillance, risk managementExperience with ancillary standards such as ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 ISO 13485:2016a plusTravelAbility to travel across the region (10% \- 15%). Occasional travel to the USmay be required.For a confidential discussion regarding this role, and our growing affiliate\-based practice \- please submit your CV/resumé and we will schedule a call. \#J\-18808\-Ljbffr **Salario Nominal****:** A convenir **Fuente****:** Whatjobs\_Ppc


