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 Affairs Engineer at Oticon Medical Nice (Vallauris, in the south of 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 work closely with R&D, Marketing and Industrialization departments. You will join the quality and regulatory affairs department and will report to the Head of RA.
Your main responsibilities will include:
- 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.
- 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.
You must have the following skills:
- 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 French and English.
As a person, you're rigorous and autonomous.
Knowledge in medical Apps or cybersecurity would be an asset.