Project Manager Labelling H/F - Grenoble, France
Date: Nov 7, 2024
Location: Saint-Egrève, FR, 38120
Company: Dentsply Sirona, Inc
Requistion ID: 78556
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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. |
Project Manager Labelling H/F - Grenoble, France
RTD - Dentsply Sirona Group specializes in the manufacture of medical, surgical and dental equipment and we are looking for a Labeling Project Manager in Saint Egrève (38120)
In this role you will be responsible for organization, coordination, management and leadership of the medical device development labeling design in our manufacturing site near Grenoble.
Responsibilities
• Responsible for organization, coordination (liaise with RA, QA, R&D, IT, Production, Purchasing), management and leadership of the medical device development labeling design.
• Execute graphic changes on Bartender, Adobe illustrator and any other software.
• Use Smartsolve to follow-up label & IFU changes.
• Leads the labeling activities of product development and product changes in accordance with FDA, CSA, EU regulations, and Dentsply Sirona’s Product Development Procedure or RTD procedure and product maintenance.
• Develops, maintains and executes project timelines for labeling activities, thereby communicating priorities, changing needs, and labeling requirements for the project team manager.
• Participates in project team meetings related to labeling.
• Assists in developing and providing regulatory information required for obtaining clearances from regulatory governing bodies, such as FDA, Health Canada, Europe, etc.
• Provides mitigation plans to maintain project schedule.
• Participates in Design Review meetings related to labeling.
• Keeps current on policies and information affecting the Dentsply Sirona SBU labeling practices, including, but not limited to, branding guidelines, regulatory issues, Global Medical Device Standards, general labeling processes, new labeling concepts.
• Develops and implements best practices and tools for label development.
• Complies with company policy and procedures.
• Perform software application validation
Profile required
• Engineering school degree (or similar) – bac +3
• Experience in labelling a clear advantage
• Regulatory mindset and project management skills
• Knowledge of PAO
• Knowledge of medical devices manufactured and/or marketed (preferred)
• Coordinating skills
• ISO 13485 :2016,
• Adobe design, Bartender software a plus
• English written
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Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please be sure to include “Accommodation Request” in the subject. |
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