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Haemonetics Corporation Global Regulatory Affairs Manager in Seattle, Washington

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.Job DetailsSummary:This position is responsible for managing sustaining regulatory activities for the Class III vascular closure portfolio (FDA, TGA, EMEA, Japan MHLW/PMDA, etc.). Key responsibilities include establishment registrations, device listings, periodic reporting, agency correspondence, as well as internal evaluation of changes, participation on cross functional teams for international staged roll-outs of approved changes, as well as interfacing with International In-Country Regulatory Affairs teams.Essential Duties and Responsibilities:Regulatory StrategyDevelop and interpret regulatory requirements from targeted global markets, recommend to Regulatory Affairs Management specific activities and resources required to support and execute strategies to further the global growth of the business.Global Regulatory ListingsEnsure that international submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations .External regulatory databases (e.g. GUDID, EUDAMED, device listings, etc.)Internal regulatory information system (RIMSys)Global regulatory filings, periodic reports, and updates as needed (e.g. annual report, Technical Documentation update)Sustaining RegulatorySupport change management and market expansion for multiple Class III products/product lines including, but not limited to:Regulatory Submissions - Class III implant e.g. FDA PMA supplements, NB significant change notifications, etc.Periodic Product Review Reports;Change Evaluations for design, process and manufacturing changes;Regulatory compliance with FDA, EMEA, TGA, Japan MHLW/PMDA, etc. and other applicable regional requirements, etc. including, but not limited to:Implement regulatory system changes to support evolving regulations and international standardsProduct technical documents/filesComplaint reviews for reportable eventsRecall / FSCA / HHE reviews and evaluationsCAPA/NCMR team memberManagement review reporting activitiesEvaluate and approve product advertising/promotional materials for regulatory complianceThis position can be delegated as a Person Responsible for Regulatory Compliance (PRRC) under EU MDR (2017/745) with responsibility for ensuring that:The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is releasedThe technical documentation and the EU declaration of conformity are drawn up and kept up to dateThe post-market surveillance obligations are complied with in accordance with the requirement of the MDRVigilance reporting obligations are fulfilledIn the case of investigational devices, ensuring that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjectQualifications:Thorough knowledge of FDA, MDR, and ISO 13485 standards, regulations and requirements and working knowledge of other international regulatory requirements.Course program(s) or advanced training in Regulatory Affairs and/or Clinical Research preferred (RAPS, SOCRA, ASQ, etc.).Strong technical knowledge of medical device products.Multi-lingual a plus.Education and Experience:Minimum 7 years of experience in the medical device industry with previous experience in regulatory and/or quality.Bachelor's degree in a science or health-based discipline required

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