Regulatory Affairs Project Manager
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Regulatory Affairs Project Manager
Are you interested in learning the regulatory requirements towards hearing aids? Do you enjoy participating in many different tasks and use your RA knowledge? Do you see collaboration as being one of the most important aspects for you? And do you want to join a global company with the purpose of delivering life changing hearing healthcare that increases the quality of people’s lives?
If your answer to the questions above is “yes” you might be our new Regulatory Affairs Project manager.
The job - Regulatory Affairs Project Manager
As RAP you will be a part of a RA team of 20 people in total. 13 placed in Denmark and seven placed in Stettin, Poland. The RA department is responsible for the different types of regulatory documentation related to the products, e.g. Safety & EMC approvals, the risk management documentation, the medical device file, and documents used for registration in countries worldwide. The RAP team is a part of the RA department.
The members of the RAP team participate in the development projects. Here they support the projects by (1) writing some of the regulatory documentation, (2) ensuring that the product is compliant with the regulation, and (3) handle the relevant stakeholders to ensure timely deliverables.
Joining us, you can look forward to the following tasks e.g.:
• Participate in the development projects as RAP to ensure that the right documentation is made
• Cooperation with R&D in the development of products
• Cooperation with the team in Poland and the homologation team
• Alignment with the other RAP’ regarding the RA processes
• Participate in optimization projects
Demant – an organization with the purpose of delivering life changing hearing healthcare
By joining the Demant team, you help bring sounds to the millions of hearing impaired all over the world that enables them to live natural lives with friends and family.
Demant strives to be the leader in high performance hearing solutions and to supply the most sophisticated technology and audiology possible. We have a relentless drive for innovation and is in the absolute forefront of technology, which improves the lives of people with hearing loss.
Demant is certified after ISO 13485:2016 and MDSAP and we have a continually focus on being in compliance also with the local requirements.
The workplace for this position is at Kongebakken, Smørum in Demark. We are around 17.000 people worldwide, and you will be cooperating with people from several places around the world.
You will find the perfect framework for your professional and personal development in a culture built on trust, openness and mutual respect. We welcome you in a growing international company where we push hard to be at the forefront of what is technically possible.
Could we be a match?
You could be a recent University Graduate (M.Sc. E or similar) but having 1- 3 years of professional Knowledge and experience with ISO 13485 & MDD, MDR (EU) from a regulated industry is preferable.
As a person you find it easy to keep the focus on the detail while you still have overview of the whole project. Delivering work of high quality and the same time making sure that we reach the deadlines comes natural to you. Finally, you are able to work in an agile project organization.
Want to join us?
Please send your CV and application as soon as possible, as we are screening applications continuously. The application deadline is February 7, 2021.
Please notice we will only consider candidates using the electronic recruitment system.
If you want more information about the position, please contact Mette B. Dyhrberg at +45 20 63 01 83.
We look forward to hearing from you.
About Demant
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. A growing business in intelligent audio solutions for gaming and office communication is also a significant part of the Group.
The Demant Group operates in a global market with companies in more than 30 countries, employs more than 15,000 staff and generates annual revenue of DKK 15 billion. Our products are sold in more than 130 countries where we create life-changing differences through hearing health.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 7.1.2021, men kan have været deaktiveret og genaktiveret igen.
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