Quality Affairs & Regulatory Affairs
Do you want to contribute to the improvement of the life experience for people with a hearing disability?
Then we might have an exciting career for you as operations quality engineer.
Oticon Medical is committed to improve the quality of life of profoundly deaf patients. For that, we develop implantable medical devices and surgical techniques to restore profound hearing loss. As a member of Demant one of the world’s largest groups of hearing health care companies, we share a close link with Oticon and direct access to the latest advancements in hearing research and technologies. Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology.
You will be part of our Quality team, which includes fourteen engaged Quality Engineers reporting to the Quality Assurance Director. Your mission is to manage the complaint handling process and the Medical Device Reporting activities in a highly regulated environment (Class III medical devices). In your daily work, you will be responsible for organizing tasks between the different stakeholders.
Your main tasks will include:
- Management of the complaint handling process including compliance of documents and procedures with intended regulations / standards, KPIs and trend analysis
- Management of daily tasks as part of the complaint handling & vigilance activities consisting in complaint file management and Medical Device Reporting
- Review and approval of complaint reports, investigation reports and incident reports
- Main contact person for National Competent Authorities regarding complaints and vigilance activities (ANSM, Bfarm, FDA, …)
- Active attendance to decisional boards regarding investigation results and feedback from field
- Interface with distributors and sales company regarding definition of roles and responsibilities in Medical Device Reporting
- Implementation of new regulatory and quality requirements in the complaint handling process and vigilance
- Leading of the decisional board related to complaint handling process
You have a master’s degree in biomedical engineering or scientific area. We expect you to have a minimum of 5 years of work experience with complaint management and medical device reporting within the medical device industry. You are familiar with the ISO 13485 standard, European Medical Device Regulation 2017/745 and the US Quality Management System Regulation 21 CFR part 820.
Fluency in English is mandatory.
As a person
You have good interpersonal, communication and writing skills
You like to share information with your colleagues
You are pragmatic and strive for efficiency in all that you do
You are good at prioritizing between different tasks to achieve your own and our common goal
You are able to drive projects
You are able to work with analytical and structured work methods and you pay attention to detail.
Because sound matters
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. As part of the Demant group, a global leader in hearing healthcare with 15,000 people in over 130 countries, we have access to one of the world’s strongest research and development teams, the latest technological advances and insights into hearing care.
Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. We work collaboratively with patients, physicians and hearing care professionals to ensure that every solution we create is designed with users’ needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them.
Because we know how much sound matters.