Are you a strong Regulatory or Design Control profile who would enjoy stepping into a central HQ position and take up an important role in ensuring a smooth and efficient market access?
Join the heart of a global R&D organisation and shape the next steps on an exciting journey
At GN, they provide the world with intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. They are on an exciting journey and lots of interesting activities are going on at this very moment. In 2020 they established a new department, Regulatory & Compliance, that is placed under Corporate Quality.
Due to continuous increasing activity in the R&D organisation, it has been decided to strengthen the Design Compliance team with two new Senior Design Control Specialists.
Drive and teach efficient design control compliance
As Senior Design Control Specialist, you will be supporting the projects in the R&D organisation on everything regarding design control. This entails contributing to the progress of product development projects and ensuring that knowledge is shared within the teams. It also includes planning, reporting and documenting the work in close cooperation with a variety of stakeholders.
A significant part of your role will also be to plan and implement the design control documentation, including usability engineering and risk management, in compliance with current regulatory standards for medical device development.
Design Control Specialist within medical devices with high ambitions
GN Hearing is on an exciting transformation moving from primarily being technical/R&D - driven towards a future, where new products are being developed with a stronger market/customer centric vantage point. In Regulatory & Compliance, you will join a team of professionals and specialists who have a great passion for what they do. The newly established Regulatory & Compliance team has extremely high ambitions to support the strategic transformation that entails an intensified focus on pursuing quality excellence. In this position, you will have immense impact on how regulatory compliance and overall quality is approached in the future.
GN Hearing is looking for a skilled and experienced RA or Design Control profile with the necessary experience from working with medical devices and electronics and who is ready for the challenge of working in this changing environment. You must be ready to set the agenda and be a competent partner for the organisation in all Design Control related matters.
It is expected that you bring minimum 3 years of experience from the medical device industry combined with some years of experience with Design Control. You hold an academical educational degree at master’s level, preferably in mechanical engineering, chemistry, software or similar. You have experience working with relevant medical device standards, guidelines, and regulations such as ISO 13485, ISO 14971, MDR, IEC 62366-1. Furthermore, you have an understanding for IEC 62304 Software standards. As a person, you have strong stakeholder management skills and thrive at being in charge and setting the agenda and thus being a valuable partner for the organisation in all Design Control related matters.
Want to know more?
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. If you want to learn more about this position before submitting your application, please do not hesitate to contact Consultant, Kasper Birkegaard Pedersen, or Senior Research Consultant, Emine Murati on tel.: +45 70 20 12 75. You can also apply via our website www.compasshrg.com and attach your CV, preferably as .pdf file. Please note that we will reply to the email address from which you send your CV.
Deadline for application: As soon as possible
Workplace: Ballerup, Copenhagen (Denmark)
Company: GN Hearing