Social network you want to login/join with:
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.
Compliance Project Manager
In this role, you will ensure Quality and Regulatory Compliance of product development, product modification and product sustaining activities with the applicable international regulations, applicable standards, Sites/Corporate rules, as well as Endo Consumables Group & Corporate procedures and guidelines.
Responsibilities
* Lead or support the maintenance/update of Endodontics Technical Dossiers (TD), Technical Files (TF) and Design History Files (DHF) according to the applicable international regulations and standards (e.g. EU MDR).
* Participate in the MDR Technical Documentation remediation. Create or remediate technical documentation according to 2017/745 EU Regulation. Compile Technical Documentation for submission to the notified bodies according to their respective guidelines.
* Quality & Design Control (HW & SW) within Endodontics, support product design change orders and new product developments as Compliance Project Manager, from feasibility up to commercialization and along the product lifecycle:
o Provide product development strategy according to the internal possible pathways.
o Work closely with multifunctional team to ensure compliance with design control, safety, functional goals requirements with a patient related focus in accordance with internal, and applicable external requirements (Corporate, Consumable Group, FDA, MDD, MDR...)
o Interact with Regulatory Affairs Specialists / Regulatory Project Managers to identify product classification and regulatory pathways for certifications (FDA, CE, INMETRO etc...).
o Responsible for identifying the applicable standards & regulations (with support of RC) specific to the project.
o Provide expertise to R&D for the applicable standards and regulations where the CPM is SME (e.g., 62366, ISO 14457, RoHS, WEEE, REACH, ISO 13485, FDA guidelines).
o Responsible for the conformity to regulation and standards of all product labelling associated to the product (IFU, Brochure, Web etc...) in case the labelling department does not have the appropriate competencies.
o Review and approve product development deliverables for accuracy and compliance all along the development process (design inputs, V&V, design outputs, marketing claims, risk management, labelling requirements, rationale etc....).
o Coordinate with the quality team of the manufacturing sites (Supplier control/agreement, transfer to production, process validation, quality controls...)
o Support product and process change control (Owners = R&D or Ops or QA) to ensure that all changes are:
+ Reviewed to ensure adequate approvals at Endodontics Group and at plant level (as applicable).
+ Assessed for their impact on TF/TD/DHF (Conduct the TF/TD/DHF update as needed).
+ Containing appropriate implementation steps and plans, including validation and product registration requirements.
+ Implemented in accordance with the design change plans (Site QA/RA Manager responsible for manufacturing change plans)
o Support as SME the risk activities during the product development and product life cycle according to the applicable procedures and requirements (e.g., ISO 14971).
o Ensure that product risk management process is defined and implemented. Support the risk management multifunctional team.
o Ensure Compliance of Risk Management file with applicable standards requirements.
o Drive the implementation/maintenance of processes the department (Product Compliance) is owner on. Umbrella owner or local site owner for the implementation of the 8000 procedures on the different sites.
o Support sites, group, corporate and regulatory bodies' audits & inspections.
#J-18808-Ljbffr