Review & approval co-ordination of labeling jobs. Main tools are Microsoft Teams Planner and onePLM
Translation coordination of labeling and regulatory documentation, professional communication with external vendors
Publication and/or uploading of approved documents on global portals
Supporting labelling system for periodic updates & reports
Print current labels for Regulatory Authority registration requests & Support with printing current/updated labels during mass changes
Represent Global Labeling as Local Project Coordinator on major projects
Process and implement labeling related change requests (ECR/ECN), support with the coordination of ECR related activities.
Support Labeling updates/revisions, graphic design including stakeholder management
Utilize and comply with Stryker’s Quality Management System including proactively verifying if requirements are met and managing changes within the Quality System
Review quality assurance documentation to support mainly product sustenance and product life cycle management.
Support risk management activities for Sustenance projects - Ensure that risk measures are conducted in accordance with State-of-the-Art requirements and are implemented correctly into the labeling.
Taking care of timely and quality deliverables for assigned projects.
Work as point of contact for all people related aspects with the stakeholders and review meetings with the team to monitor progress of projects and provide guidance, develop contingent plans, and arrange resources as needed.
What you need:
A relevant bachelor’s degree (science/engineering)
Strong Work experience: 7-10 years out of which 5+ years’ experience in designing, writing, and publishing technical documentation (labelling/technical publication/collateral materials) and/or Design Quality Assurance) or new product development (medical devices)
Excellent verbal and written communications
Knowledge of EU MDR changes, ISO 14971, IEC 62366, Quality Concepts (e.g. CAPA, Audits, Statistics) preferred
Must possess strong project management skills as well as can manage multiple tasks simultaneouslyDemonstrated ability to advocate for product excellence and quality.
Great organization, capability to follow a given plan
Ability to brainstorm potential solutions and execute acc. to plan
Knowledge in systems and databases, preferred onePLM (CAII ideal), sharepoints and online applications
