Bengaluru, IND
18 hours ago
Staff Specialist, Labeling and Technical Publications
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. **What you will do:** **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 simultaneously** **Demonstrated 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** Stryker 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 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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