Risk Management Officer

GN Hearing
Ballerup - Denmark
Published: June 04, 2018
Can you interpret, align and coordinate top level risk management activities? Do you enjoy collaborating with stakeholders from different functions? And would you like to join a global leader in intelligent audio solutions?

Transforming lives through the power of sound
At GN Hearing, we know sound, and with our ReSound® hearing aids, we offer solutions that let our users hear more, do more and be more than ever thought possible. Joining our Design and Compliance Review team within Corporate Quality, you will play a key role in ensuring that we can continue to create and deliver products of the highest quality to our users.

Ensure regulatory compliance through risk management
As our new risk management officer, you will contribute with risk assessments through the entire product lifecycle – from initial idea conception to production and use. Making sure that risk management activities are integrated into our processes, you will collaborate cross-functionally with everyone from R&D to Manufacturing, including stakeholders within clinical evaluation, cyber security, regulatory management and marketing.

Developing, implementing and maintaining global procedures related to risk management, you will:

• Monitor and interpret risk management related standards and methods within the medical device industry (ISO 14971, ISO 13485, IEC 62304, etc.)
• Drive the standardisation of risk management processes and documentation
• Maintain risk management training plans for project managers and key stakeholders
• Participate in post-market surveillance activities and drive risk management activities based on the conclusions from the surveillance
• Support homologation activities in relation to risk management

You will be based at our Danish HQ in Ballerup, near Copenhagen, but will be working with all entities within the global GN Hearing organisation, and you can expect to travel about 30 days a year.

We listen to the market
While you will be working independently as a representative for Corporate Quality in various projects across the organisation, you will also become part of a specialist team, currently consisting of 15 highly skilled colleagues. We aim to integrate risk management considerations as seamlessly as possible into the natural flow of e.g. product development. Listening to the needs of the business, we translate requirements and find solutions that support our overall commercial strategy.

Solution-oriented communicator with technical insight
As risk management is one of the cornerstones of our quality assurance, you need the ability to not only set the parameters for risk management – but also to inspire and coach your colleagues to prioritise the area. With your solution-oriented approach, you quickly become a trusted partner to the business. Moreover, you have excellent communication skills, allowing you to translate regulations into actionable solutions.
• You bring deep knowledge of and experience in risk management.
• You preferably have a degree in engineering or similar.
• You have experience from a regulated industry – preferably medical devices.
• You bring experience from working with quality systems and hardware/software development.
• You speak and write English fluently.

Would you like to know more?
To apply, use the ‘APPLY’ link no later than 25 June 2018. Applications are assessed on a continuous basis, which is why we encourage you to send your application as soon as possible.
If you want to know more about the position, you are welcome to contact Head of Design & Compliance Review Henrik Povelsen on +45 2366 0287.

About GN Hearing
People with hearing loss are at the heart of everything we do. ReSound® hearing aids help people feel more involved, connected and in control. In an ever-smarter world, we think big and challenge the norm so that we can transform lives through the power of sound. Available exclusively through audiologists and hearing care professionals.

ReSound is part of The GN Group – pioneering great sound from world-leading ReSound hearing aids to Jabra office headsets and sports headphones. Founded in 1869, the GN Group today has more than 5,500 employees and is listed on Nasdaq Copenhagen (GN.CO).

For the purpose of processing your job application, GN will process your personal data. We encourage you not to provide us with sensitive information (e.g. racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health information, or sexual orientation) about yourself. Your application will be transferred to the local GN office posting this job. For information about how GN processes your personal data, please read our » privacy policy .