Would you like to work for a company that supplies and sells products and services in the field of imaging diagnostic equipment, ultrasound systems and medical IT systems and would you like to travel for work? Then this is you perfect job.
This position is a leader of regulatory and QMS in EMEA and recent mission is to comply MDR & regulatory requirement for Medical devices and support to achieve the strategic target of the company. You are managing the MDR project to align with KMI in Japan directly and provide exact information to comply MDR perspective and complete the project until execution date of MDR as on 26th May 2021. You take the lead of project in Europe side and contact relevant persons/departments in BEU headquarter in Germany. You complete QMS and maintain it continuously according to MDR together with BEU process managementteam. An PRRC-support role for MDR is also expected.
- You have regulatory responsibility for EU authorized representative and importer for Medical Device in the company;
- You support process management with headquarters in Germany to maintain QMS in the company according to regulatory requirement;
- You are managing the post market process, which may include taking lead of recall and communication with competent authorities. It also includes all type of certifications / registrations requested by authorities in Europe;
- You are reporting to the management of the company and headquarter, which is a medical device manufacturer outside EU, to provide exact situation and progress of regulatory topics of the company;
- You translate requirements for regulatory topics follow up appropriately and take needed actions into Europe organization;
- You take responsibility to support PRRC (Person Responsible for Regulatory Compliance) for MDR;
- You are supporting ISO 9001 certification activity to revise and renew QMS;
- You align with headquarter in Germany to complete necessary actions to be done by relevant departments and persons;
- You are monitoring further necessary actions and compliance for MDR continuously after the execution.
To qualify for this position:
- You have five years of successful and verifiable regulatory experience in Medical Imaging or similar field;
- You have solid understanding of the radiology and ultrasound business in human and veterinary environments;
- You have experience with project management;
- You have experience in Regulatory affairs;
- You have an strong knowledge of Medical Devices directives & regulation (MDD & MDR);
- You have knowledge of ISO 13485 and ISO 9001;
- You have knowledge of Medical Imaging Devices such as X-ray, DR, CR, FILMS, Ultra Sound, RIS/PACS;
- You have strong leadership skills to lead project management requested;
- You are understanding cultural differences;
- You have excellent communication, negotiation and presentation skills;
- You have excellent oral and written communication skills in English. Dutch would be a plus.
You must travel for this position and it is a position for 32 to 40 hours a week.
Our client provides and sells products and services related to imaging diagnostic equipment, ultrasound systems, and medical IT systems.
They have contributed to the development of medical care by improving the accuracy of diagnostics and reducing the burden on patients through the use of imaging technologies that visualize invisible things.
In addition to supporting the medical front lines through the digitization of X-ray images and diagnostic imaging using ultrasound, they provide a total range of devices, systems, and ICT services that contribute to the digitization and networking of the medical field, and contribute to the realization of faster and more reliable diagnostic services.