Biomedical Engineer or similar for Regulatory Affairs – Graduate Friendly opportunity
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Ballerup
If you have interest in the Medical Device industry and for Regulatory Affairs and quality, we are keen to present this opportunity to work with a wide range of tasks that will help ensure many exciting product releases in the near future.
Join GN Hearing in delivering great hearing aids to users all over the world
At GN Hearing, we provide sophisticated hearing aid solutions to transform lives through the power of sound. We make life sound better!
As part of our continuous focus to deliver innovative and safe products to market we are adding a new headcount in our RA team.
Our close RA Team
You will join an ambitious team that are close to each other and collaborate to ensure a nice work environment and allow us to develop and explore new skills. Currently the team consist of 5 permanent highly skilled and dedicated people located in Ballerup. The team will consist of 6 people driving change management, New Product Development (NPD) and Sustaining activities.
Collaboration is everything
The jobs focus on the true team effort of developing medical devices consisting of many different types of components developed by a variety of subject matter experts (SME’s) in our R&D team.
As our new Assistant Regulatory Affairs Specialist colleague in Regulatory Affairs, you will be working closely with different types of people within the many exciting programs. The goal is to provide solutions and a fast to market pathway to ensure the program/project timelines and deliverables enable us to provide people with hearing disability a life that sounds better.
Key Responsibilities as our new Assistant Regulatory Affairs Specialist
Qualifications:
We imagine that there are several ways to succeed in the role, but your background and experience could include some or more of the following experiences:
Interested?
If you want to know more about the job you can contact hiring Team lead, Cindie Vandfeldt by connecting with her on LinkedIn or by phone +45 2788 9645.
Please submit your CV through our “APPLY” button in our Applicant Tracking System, Workday. We kindly ask you to apply before February 20, 2022. We hope to find our new colleague as soon as possible and by April 1, 2022 the latest.
We look forward to hearing from you!
How was your experience with the job ad, and what can we do to improve?
We care deeply about the people who consider applying for a job at our company. We hope that you will share your honest feedback by answering 7 anonymous questions in the link below:
https://app.talenthub.io/feedback/c5c46cb25d124cec84abad7008c008e4
Note: the link will work on all devices - computer, mobile or tablet!
#LI-Resound
Join GN Hearing in delivering great hearing aids to users all over the world
At GN Hearing, we provide sophisticated hearing aid solutions to transform lives through the power of sound. We make life sound better!
As part of our continuous focus to deliver innovative and safe products to market we are adding a new headcount in our RA team.
Our close RA Team
You will join an ambitious team that are close to each other and collaborate to ensure a nice work environment and allow us to develop and explore new skills. Currently the team consist of 5 permanent highly skilled and dedicated people located in Ballerup. The team will consist of 6 people driving change management, New Product Development (NPD) and Sustaining activities.
Collaboration is everything
The jobs focus on the true team effort of developing medical devices consisting of many different types of components developed by a variety of subject matter experts (SME’s) in our R&D team.
As our new Assistant Regulatory Affairs Specialist colleague in Regulatory Affairs, you will be working closely with different types of people within the many exciting programs. The goal is to provide solutions and a fast to market pathway to ensure the program/project timelines and deliverables enable us to provide people with hearing disability a life that sounds better.
Key Responsibilities as our new Assistant Regulatory Affairs Specialist
- Coordinate cross-functional activities to compile the Technical Dossier per known NPD procedures and processes
- Responsible for providing input to the regulatory strategy and ensure that the program/project is on track.
- Conduct review of the technical documentation to ensure compliance with requirements by the support of relevant SME´s
- Provide guidance to other stakeholders within R&D to ensure that requirements to the technical documentation are known and understood
- Act as one point of contact between program/project and relevant Subject Matter experts
- Ensure that the technical documents/deliverables are ready for milestone gating (development stages in the R&D process) per procedures and processes
- Responsible for reporting status and issues to Program Manager and RA Team Lead
- Provide input to continuously develop and improve existing NPD and Regulatory processes
Qualifications:
We imagine that there are several ways to succeed in the role, but your background and experience could include some or more of the following experiences:
- A relevant educational background or hands on experience that enables you to understand the complexity of a hearing aid product
- Ability to read and understand complex regulatory requirements
- Ability to follow these requirements that allow us to release according to planned activities
- Ability to operate within a fast-pacing environment
- Have a can-do attitude
Interested?
If you want to know more about the job you can contact hiring Team lead, Cindie Vandfeldt by connecting with her on LinkedIn or by phone +45 2788 9645.
Please submit your CV through our “APPLY” button in our Applicant Tracking System, Workday. We kindly ask you to apply before February 20, 2022. We hope to find our new colleague as soon as possible and by April 1, 2022 the latest.
We look forward to hearing from you!
How was your experience with the job ad, and what can we do to improve?
We care deeply about the people who consider applying for a job at our company. We hope that you will share your honest feedback by answering 7 anonymous questions in the link below:
https://app.talenthub.io/feedback/c5c46cb25d124cec84abad7008c008e4
Note: the link will work on all devices - computer, mobile or tablet!
#LI-Resound
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 15.10.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Ballerup
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