Quality Affairs & Regulatory Affairs (ba_FR_OTM_QARA)
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 Regulatory Engineer FDA H/F at Oticon Medical in Vallauris (France).
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 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.
In your new position, you will join the quality and regulatory affairs department and will work closely with R&D, Marketing and Industrialization departments.
Your main responsibilities will include:
- Preparation and follow-up of PMA file and supplements of class III devices.
- Work with the product team to develop regulatory strategies for the approval of new medical devices or their changes.
- Determine and communicate to the teams of R & D/industrialization/Validation, regulatory requirements for the development and registration of new products, and provide the appropriate procedures
- Handle the risk management process of the projects
- Check the conformity of the DHF and DMR.
- Check the technical documents related to the products changes, including changes of processes and materials.
- Évaluer l'impact des nouvelles normes techniques et règlementations et participer à la mise en place des actions.
- Assess the impact of the new technical standards and regulations, and participate in the implementation of the actions.
- Ensure continuous improvement of the process in its areas of expertise
- Support the export registration team
Skills and experience
Engineer or equivalent, and you have at least 5 years’ experience in regulatory affairs related to the development of medical devices. Desired experience in preparation and follow-up of 510K (or PMA).
You must have the following skills:
- Knowledge of American regulations (21CFR).
- Successful experience in review and preparation of technical documents to ensure their clarity, accuracy, comprehensiveness and structure.
- Experience in the regulatory field of product/process changes and approval process of medical devices.
- Ability to interpret regulations on active implantable medical devices and to apply the requirements of quality systems standards such as the ISO 13485 and 21 CFR 820.
- Successful experience in highly regulated industries such as medical devices or pharmaceuticals.
- Understanding of the technical specifications and protocols used to test devices in accordance with international standards.
- Ability to work actively with multidisciplinary teams.
- Highly organized, spirit of synthesis, good editorial skills and communication
- Fluent in English is necessary in writing and oral.
As a person, you are rigorous and autonomous.
Our commitment to making a difference
Together with skilled colleagues, you are part of a dynamic environment based on trust and openness, and you will experience a strong passion for our patients. We are a growing international company where everybody supports the business by making sure we successfully bring the best experience with our products to our users. You will be working in a bright and open workplace, where a flexible working environment, knowledge sharing and professional respect makes it meaningful to go to work.