Dentsply Sirona Overview
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.
The company 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.
Compliance Project Manager Role
This role ensures Quality and Regulatory Compliance of product development, product modification and product sustaining activities with the applicable international regulations, standards, Sites/Corporate rules, as well as Endo Consumables Group & Corporate procedures and guidelines.
Key Responsibilities
* Maintain/update Technical Dossiers (TD), Technical Files (TF) and Design History Files (DHF) according to international regulations and standards.
* Participate in the EU MDR Technical Documentation remediation and create/remediate technical documentation.
* Ensure Quality & Design Control within Endodontics, supporting product design change orders and new product developments as Compliance Project Manager.
* Provide product development strategy and work closely with multifunctional teams for compliance with design control, safety, functional goals requirements.
* Interact with Regulatory Affairs Specialists to identify product classification and regulatory pathways for certifications.
* Identify applicable standards & regulations and provide expertise to R&D for relevant standards and regulations.
* Review and approve product development deliverables for accuracy and compliance during the development process.
* Coordinate with manufacturing sites' quality teams for supplier control, transfer to production, process validation, and quality controls.
* Support product and process change control to ensure adequate approvals, assessments, and implementation steps.
* Support risk management activities during product development and lifecycle according to applicable procedures and requirements.
* Ensure product risk management process definition and implementation.
* Drive the implementation/maintenance of processes owned by the department (Product Compliance).
Requirements and Expectations
1. Deep understanding of international regulations, standards, and corporate rules.
2. Strong analytical and problem-solving skills.
3. Excellent communication and collaboration skills.
4. Ability to prioritize tasks and manage multiple projects simultaneously.