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Regulatory Affairs Specialist with Life Cycle Management Interest

Företag GN Group
Ort
Kategorier
Utgår

2022-05-22

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Regulatory Affairs Specialist with Life Cycle Management Interest

Our Regulatory Affairs team at HQ in Ballerup, are seeking 1 new Regulatory Affairs Specialist.

Joining GN Hearing and delivering great hearing aids

At GN Hearing, we provide sophisticated hearing aid solutions to transform lives through the power of sound. We make life sound better!

To support our continuous focus on delivering innovative and safe products to market we seek to add 1 new headcount to Cindie Vandfeldt´s team. Currently the team consist of 6 highly skilled and dedicated people located in Ballerup. The team will when fully staffed consist of 7 people (this new headcounts included) responsible for areas such as Key Accounts programs, sustaining projects and Change management just to mention a few  

Collaboration is everything

The job focuses on the true team effort of developing medical devices consisting of many different types of components developed by a variety of subject matter experts in our R&D team. As Regulatory Affairs Specialist your structure and communication skills will ensure and enable us to identify who, what and when to ensure that programs/projects are on track to meet business priorities.

By collaborating closely with a Program/Project Manager and other stakeholders within the project team you must be able to focus and drive the readiness of the technical documentation by overseeing timelines and deliverables.

Key responsibilities

  • Coordinate cross-functional activities to compile the Technical files per known New Product Development (NPD) procedures and processes
  • Ensure readiness of completed technical documentation in conjunction with Design Control specialist
  • Provide guidance to colleagues within R&D to make sure the list of tasks required as part of the technical documentation is known and understood
  • Act as one point of contact between program/project and relevant engineering experts within areas such as mechanics, hardware, software, and audiology
  • Responsible for reporting status/issues to stakeholders e.g., Regulatory Affairs team Lead, and Program Manager.
  • Provide inputs to continuously develop and improve existing NPD and Regulatory processes

We believe that we have several amazing colleagues with knowledge of our products and the regulatory processes that we work with. These colleagues will help ensure our success together with your talent for bringing people together to deliver.

To succeed in the role as Regulatory Affairs Specialist you must have:

  • Hands on experience within Regulatory Affairs. Hearing Aid industry experience is a plus
  • Like to interact and communicate with all sorts of people across the organization
  • Like to juggle multiple projects simultaneously
  • The ability to keep calm, cool and collected

We also expect you to be:

  • MS Office super user (PowerPoint, Teams and Excel)
  • Proficient in English, our corporate language
  • Curious and eager to learn as well as share your previous experience and knowledge
  • Preferable experienced with our documentation system Agile
  • Eager to share your experience and knowledge within RA

What you will learn

Beside what it means to work within the hearing aid industry and how things are done here, you will learn a lot about stakeholder management, RX/OTC devices, how to classify for a wide variety of countries, create technical documentation and technical files for a variety of countries and be part of our new registration strategy for EU.

Our workplace offers plenty of different benefits and flexibility to keep us happy and healthy. This allows us to concentrate on what matters in and outside of work. We hope you are curious to explore and engage in the recruitment process with us.

Would you like to know more?

To apply, use the ‘APPLY’ link no later than May 22. We encourage you to submit a CV and look forward to hearing from you.

We hope to conduct interviews during May/June and that our new colleagues can start in August 2022 or maybe even sooner.

To learn more about the role, feel free to connect with hiring manager, Cindie Vandfeldt on LinkedIn: https://www.linkedin.com/in/cindie-vandfeldt-9215a827/

Dela detta jobb

Regulatory Affairs Specialist with Life Cycle Management Interest

GN Group