Are you ready to make a difference for people with a severe hearing disability and are you fueled by professional pride and curiosity? Are you skilled within the area of high-tech new product development and motivated to work on innovative implantable hearing solutions?
Then we might have an exciting opportunity for you as Regulatory Affairs Specialist at Oticon Medical.
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
In your new position, you will join the Regulatory Affairs – Development & Changes department.
Your main area of responsibilities will be:
• Develop / participate to RA strategies in collaboration with different Departments such as R&D, Engineering, Marketing, Clinical Research.
• Participate to R&D Projects and any other planned transversal projects.
• Review appropriate technical documentation and participate to Design Reviews to ensure CE marking of medical devices.
• Coordinate and/or approve labeling, promotional documentation, ensuring compliance with technical documentation and applicable regulations.
• Prepare Technical Documentation and submit to Notified Body (NB) if applicable. Coordinate with NB and internal stakeholders until getting CE Certificate approval.
• Maintain Technical Documentation through product lifecycle, ensuring documentation traceability in case of product change, NB submissions, NB or Competent Authorities requests, CAPA, …
• Review, evaluate and approve any change orders.
• Ensure and maintain high level of knowledge of EU legislation and any regulations applicable to medical devices while ensuring active RA monitoring/watch.
• Promote the regulatory culture towards the entire personnel.
• Ensure continuous improvement of processes in areas of expertise.
• Support the International registration of products.
• Participate to internal/external audits.
• Support QA while creating/maintaining any QMS document applicable to RA activities.
• If needed, support non-conformities/CAPA processes.
The profile we are looking for
• Engineering degree or Master 2 in a technical field (biomedical, electronic, software, …) needed to understand details and regulatory issues related to the implantable medical device.
• Proven experience reviewing and editing technical documents to ensure clarity, accuracy, completeness, logical flow and structure.
• Ability to interpret regulations related to the implantable medical device and apply knowledge of all relevant standards applicable to medical devices.
• 1st experience in medical device and regulatory affairs (3 years minimum)
• Ability to work transversely and actively with multi-disciplinary teams
• Organization, team worker, sense of synthesis, good writing and interpersonal skills
• Reactivity, rigor, autonomy, capacity to analyze and synthesize
• Good communication skills both written and spoken with French and English
We dare to make a difference
Together with skilled colleagues, you are part of a dynamic environment based on trust and openness, and you will experience a strong will to win. We are a growing international company where everybody supports the business by contributing to the customers’ experience of our products as the most attractive to work with. You will be working in a bright and open workplace, where a flexible working environment, knowledge sharing and professional respect makes it both challenging and meaningful to go to work.
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.