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Senior Regulatory Affairs, Project Manager, EMEA
4 maanden geleden
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 RA/QA 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/Quality Assurance team:
Position Summary
Under general direction, responsible for the leadership and directing of complex projects, which often require resources and functional integration. Responsibility for all aspects of the project from initiation to completion.
Interfaces with all stakeholders affected by the project, including end users.
Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes across Europe, Middle East and Africa.
Provide maturity and significant RA experience and expertise to the EMEA RAQA team to accelerate market access.
Partner with the business by driving regulatory processes and activities through strategic projects.
Key Activities & Accountabilities
Leads the execution and delivery of the EMEA registration plan for assigned franchises and building high quality regulatory dossiers to achieve timely regulatory approvals and renewals.Primary contact with assigned Stryker Design Divisions on market clearance and renewal activities, ensuring ongoing market access in line with business strategy.Supports the execution of submission strategies / registration planning in EMEA in collaboration with RAQA management.Maintain active participation in product lifecycle management planning and associated RA execution.Build, implement and maintain effective product registration processes.Partner with International RA teams to promote sharing of best practice and leveraging of product documentation to accelerate market access. Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RAQA management.Very good acquaintance and understanding of RA/QA /PMS procedures and processes.Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverablesResponsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team membersLead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.Responsible to improve team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.May coordinate the activities of one or more exempt and/or non-exempt employees.Provides support to EMEA / Country RAQA teams as appropriate.Education
BA or BS (emphasis in management or related discipline preferred) or equivalent.
Experience
Minimum of 6 years’ project management experience in Regulatory Affairs required.
PMP certification or equivalent () desired.
Prior divisional or site experience desired.
Prior cross-site/division experience desired.
About StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at
