Regulatory Affairs Specialist
Oticon Medical AB / Byggjobb / Göteborg
2018-10-22
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hela Sverige Visa alla jobb hos Oticon Medical AB i Göteborg Oticon Medical is part of William Demant Holding with more than 13.000 employees across the world and revenues of over DKK 13 billion. Oticon Medical is the fastest growing manufacturer of bone anchored and cochlear implant hearing systems for children and adults. At Oticon Medical we combine more than a century of experience in audiology and sound processing from Oticon with decades of pioneering experience in hearing implant technology. Our connection to Oticon gives us unique access to knowledge, resources and technology that we use for developing innovative and life-changing implantable hearing
Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then we can offer you the right challenge!
Right now, we are looking for a dedicated and highly skilled Regulatory Affairs Specialist to support our fast-growing business and international expansion.
Based at Oticon Medical AB in Askim, Sweden you will become part of an interdisciplinary environment at Oticon Medical's offices in Gothenburg and Copenhagen, Denmark.
Your offer
In your new job, you will primarily work with product development projects related to the implant part of our bone anchored hearing solutions and support the projects with regulatory input.
This includes but is not limited to; *Represent QARA in assigned product development projects; guide the project in quality system compliance and ensure regulatory compliance of developed products
• Establish regulatory plan for assigned projects
• Secure establishment and regulatory compliance of product documentation
• Lead the accomplishment of risk management activities
• Support development of product labelling and ensure compliance with product claims and achieved product registrations
• Perform product registrations worldwide, either directly or through distributors
You will also support implementation of the new MDR in new development projects and within the current product assortment. You can look forward to joining a cross functional product development team as a core member.
You will in addition be part of the RA team consisting of 3 dedicated and highly skilled colleagues. To ensure sufficient collaboration with the projects you are expected to spend 1-2 days a month in our offices in Denmark and / or France. As part of the product registrations you will also be working closely with our distributors.
What we are looking for
We are looking for someone with a passion for efficiency, structure and regulatory compliance and understand the challenges of working in a fast-growing environment.
You should have worked at least 3 years with regulatory in a medical device company. Basically, you have thorough understanding of AIMDD or MDD, ISO 13485 and QSR.
You are an outgoing and positive team player who can work structured and independently coordinating your own work but also by working as a team in a cross functional project with your colleagues.
Your professional style is characterized by your ability to work structured and focused in a technical and professional manner. Besides that, we expect that you are pragmatic and strive for efficiency in all that you do.
Application
To apply for this position please attach your CV and personal letter in English by using the link "Apply now". We would like to hear from you no later than 16 November 2018.
For more information please contact Satu Hjärtstam +46 735 44 98 13
We are looking forward to hearing from you!
Publiceringsdatum2018-10-22Så ansöker duSista dag att ansöka är 2018-11-16
Klicka på denna länk för att göra din ansökanFöretagOTICON MEDICAL AB
KontorsadressDatavägen 37B
Jobbnummer 4415575
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