For our German branch (Nipro Pure Water) in Bruchsal, Germany
Reports to: Business Manager Nipro Pure Water
The role holder is responsible for ensuring that Nipro Pure Water meets all requirements of the current European Medical Devices Directive and/or any other regulatory aspects connected to Nipro Medical Europe products and/or organization.
This position reports directly to the Business Manager of Nipro Pure Water and has final authority over all Quality Assurance matters.
- Perform all tasks in accordance with ISO 13485 quality requirements and NPW procedures and taking Nipro values into account.
- Demonstrates flexibility and mobility in order to optimize contact with the different business units and entities
- Under the guidance and directions of the Business Manager of Nipro Pure Water, to achieve agreed functional and personal objectives within area of responsibility.
- The RA Manager has end-responsibility over the Technical Files.
- Monitors and implements changes in the Regulatory field affecting the company, its products or environment. Actively monitors EU regulation, MDD, MDR
- Working with other relevant internal and external parties (warehouse, suppliers, customers), leads the CE marking process ensuring timely, cost effective and efficient acquisition of CE marking for NPW products.
- Professionally represents NPW management, internally and externally, on all regulatory issues and matters.
- Effectively manages, in line with procedures, all regulatory documentation connected with medical devices; records, document preparation, document approvals and document release.
- Effectively manages, in close collaboration with the Nipro Medical Europe regulatory department, product registration under the current MDD, and ensures all requirements are met, costs are managed and timely registration achieved
- Directly responsible, in close collaboration with the MDR Project Director, for ensuring NPW compliance with European Medical Devices Directive.
- Provides regular reporting, to Management Team, on compliance status.
- Under the guidance and directions of the Business Manager of NPW, to achieve agreed functional and personal objectives within area of responsibility.
- Manages through its team the Corrective and Preventive Actions system, monitoring non-compliances, customer complaints and satisfaction, leading corrective actions and undertaking timely and effective follow up.
- Professionally represents NPW management, internally and externally, on all quality issues and matters.
- Effectively manages, in line with procedures, all quality documentation connected with medical devices; records, document preparation, document approvals and document release.
- Is accountable for incident reporting to the Competent Authorities.
The role holder is responsible for developing, maintaining, monitoring and reporting on the NPW organizational management system (NPWMS).
- Creates, implements and continually updates a Management System in accordance with the Company policies and with all regulations and ISO 13485 standard.
- Reports to the Managing Director about the functioning of the Management System, with the aim to analyze the results obtained so far and to continuously improve the Management System
- Evaluates the inputs for the analysis by the Management Team and reports the outputs of the analysis by the Management Team.
- Helps control the policies, the objectives and the management programs involved.
- Responsible for managing all documentation related to the QMS and for the correct and timely distribution of new and/or modified documents and procedures.
- Controls the interaction of the different processes in the system.
- Manages characteristics and trends from the NEMS, including opportunities for preventive measures.
- Promotes internal consciousness about quality, the environment and expectations from customers.
- Manages the process of continuous improvements.
- Controls, measures, analyzes and improves processes meant to guarantee the conformity of the NPWMS.
- Controls the evaluation of suppliers.
- Effectively manages, in line with procedures, all quality and regulatory documentation connected with medical devices; records, document preparation, document approvals and document release.
- Directly leads and manages NPW internal audit team, audit process and timetable. Where necessary, conducts audit on suppliers premises.
Please send us your latest CV and motivational letter to:
Nipro Pure Water GmbH
attn. Rebecca Leier