About StrykerStryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.We are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.comWhy regulatory affairs/quality assurance at Stryker? Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World’s Best Workplaces, apply now! Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-teamJob Title : Regulatory Affairs Specialist (Post Market Surveillance)Position SummaryDevelops and applies intermediate knowledge and understanding of the Post Market Surveillance (PMS) frameworks, legislative requirements, processes, and procedures in the EMEA distribution organisation. Handle hub and spoke teams to establish, implement, and maintain EMEA Regulatory and Quality processes, tools and documents supporting our Corporate QMS.The position is engaged in a matrix organisation newly created within Post Market Surveillance, named Central Team with reporting line to Lead Functional Manager.Key Activities & Accountabilities Executes PMS activities in line with defined procedures and processes. Implement post market strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)Reports product safety issues to regulatory authorities as required, to comply with local, regional and global regulationsAssesses regulatory intelligence to assist in the development of local, regional regulatory strategiesCollet local, national, international Post Market Surveillance requirements and options for regulatory submission (adverse events) and compliance activitiesIdentifies the need for new post market procedures, SOPs and participates in development and implementationSupports the development and deployment of new systems and procedures locallySupports continuous improvement activities across PMS processes at the regional level,Supports integration of new acquisitions & PMS processes alignment Liaison with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizationsPerforms based on established targets, KPIs and objectives for RAQAProvides support to EMEA / Country RAQA teams and included activities sitting under the franchise lead role when requestedPrepare regular reports as requested: weekly / monthly reports, support quality management meetings and audits preparation and readinessIdentify training needs and deliver training at any organisational levelUpdate and develop training material in the relevant knowledge domainProvide training to stakeholders on current and new Post Market Surveillance requirements to ensure organization-wide complianceAssists other departments in the development of SOPs to ensure post market complianceEducationBSc in Engineering, Science, or related ExperienceTypically, a minimum of 3 years’ experience.Prior divisional or site experience desiredPrior cross-site/division experience desiredKnowledge/Competencies Demonstrated knowledge and application of Medical Device Directive, EU/FDA Medical Device Regulations, Quality System and Post Market Surveillance requirements / Regulatory IntelligenceDemonstrate technical & scientific knowledge of medical device regulation and quality requirementsUsually works with minimum supervision, conferring with superior on unusual mattersSeeks out diverse ideas, opinion, and insights and applies them in the workplaceConnects and relates well with people who think and act differently than oneselfEmbraces scrutiny and accepts feedback as opportunity to learn and improveChooses the best alternative to achieve desired outcome or effect,Willingly accepts challenging assignments and new career opportunities that stretch and build capabilitiesClearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors.Engages in communication with regulators and other key stakeholders on routine and complex matters Be active in preparation for meetings with regulatory agencies, internal and external audits and other stakeholders.Be active in preparation of briefings and other information documents.Accountable for local process and training implementationPreparation & analyse of PMS metrics for reporting purposes. High attention to detail and process consciousnessStrong IT skills, including Microsoft Office.Fluent in English (+ local language where applicable).Our benefitsOur total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.Know someone at Stryker?Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
Lead Post Market Surveillance Specialist in Bucuresti
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