Regulatory Affairs Country Specialist
Oticon Medical AB / Elektronikjobb / Göteborg
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hela Sverige Visa alla jobb hos Oticon Medical AB i Göteborg Making people hear again with our bone-conducted hearing solutions is a truly amazing technology and goal. We aim to better life quality because we believe that sound matters. If you truly want to make a difference for people with hearing disability, then this is your opportunity. Our background storyOticon Medical AB is part of Demant Group. Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss connect and communicate with the world around them. For more than a century, the Demant Group has played a vital part in developing innovative technologies and know-how to help improve people's hearing and health. In every aspect, from hearing devices, hearing implants and diagnostic equipment to hearing care all over the world, Demant is active and engaged. We employ more than 14,000 world-wide and are a growing business in intelligent audio solutions for gaming and office communication is also a significant part of the Group. Our journey has begun, do you want to join?We are a team of three based in the office in Askim, Sweden. We are responsible for ensuring regulatory product compliance. It is our job to ensure product registrations worldwide and provide guidance for quality system compliance during development projects. We follow AIMD, MDD, ISO 13485, and QSR etc. To describe your team in the best way, we believe in a collaborative and open culture. We depend on each other to share know-how's and challenges because we believe that the best results come from a fruitful team effort. We work interdisciplinary and across countries with our colleagues in Copenhagen and Nice. As part of the product registrations you will also be working closely with our distributors worldwide. Hence, you should expect to travel around 15 days annually. Responsibilities in shortA description of an everyday can be difficult to provide, as we claim that we do not have two days alike. We will try to provide you with an overview of what you will be responsible for. Your main responsibility is to participate in creating worldwide regulatory strategies and provide regulatory input to product launch plans. Furthermore, you will prepare regulatory documentation for product submissions, licence renewals and periodic updates. To do a good job, you need to find it easy to convert and translate technical documentation into the regulatory demands. In your role as a regulatory affairs specialist you also work as a project managerresponsible for coordinating cross-functional activities to enter new markets. As part of your work you will also conduct distributor quality management system audits and support development of relevant SOPs as well as work instructions. What we are looking forYou are passionate about efficiency, structure and regulatory compliance and understand the challenges of working in a fast-growing environment. The basics to perform well:You have at least 1-2 years working with QA/RA, preferably with medical devices. You have at least basic understanding of AIMDD or MDD, ISO 13485, and QSR.As we are a global company, you communicate effortlessly in English and are used to write in English. If you have French or Spanish language proficiency we consider this as meriting. We know you can! We trust and value your professionalism, experience and dedication. Your new perspectives, insights and ideas are the cornerstones of our success, and we encourage you to think out of the box and participate developing our ways of working. Want to see it from our side?To apply for this position please attach your CV and short motivational letter in English not later than June 7, 2019, by using the link "Apply now".Please note that we only accept applications send through our online web platform. Don't hesitate to reach outFor more information about the job, please contact Satu Hjärtstam, Head of Regulatory Affairs on +46 735 44 98 13 .If you have questions to the recruitment process please reach out to Ditte Mi Petræus on +45 5381 3547 We are excited to get to know you. About Oticon MedicalOticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. We are part of the Demant Group - one of the world's largest groups of hearing health care companies with more than 14,000 employees worldwide and revenues of over DKK 14 billion. We share a close link with Oticon and have 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. By working collaboratively with patients, physicians and hearing care professionals, we ensure that every solution we create is designed with user 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.
Publiceringsdatum2019-05-09Så ansöker duSista dag att ansöka är 2019-06-07
Klicka på denna länk för att göra din ansökanFöretagOTICON MEDICAL AB
KontorsadressDatavägen 37B
Jobbnummer 4776408
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