Do you want to be the driving force behind developing, implementing and maintaining our global biological evaluation activities?
Then grab this unique opportunity to create value for the organization as you influence and optimize the way we work with biological evaluation – enabling us to continue to transform lives through the power of sound.
Welcome to GN Hearing – we make life sound better
At our global HQ in Ballerup, you will join 12 colleagues in Regulatory Affairs, part of Corporate Quality. We are a highly specialized team who are globally responsible for making sure that our hearing aids and accessories as well as manufacturing processes meet legislative requirements as well as GN Hearing’s own requirements.
Build our biological evaluation management area
As our only biological evaluation officer, you will be able to shape your area and gain a global reach across the organization.
Stakeholder management will be essential to your work as you help ensure that biological considerations become an integrated part of program and product development. You will collaborate closely with internal stakeholders such as R&D, Global Procurement, Supplier Quality and global manufacturing sites as well as external authorities and test laboratories.
More specifically, you will:
- Be a process owner of biological evaluation in GN Hearing
- Monitor and interpret biological evaluation management standards and methods within the medical device industry (i.e. the ISO 10993 series)
- Maintain training plans and train the team, program and project managers and key stakeholders in biological evaluation management
- Review and approve biological evaluation plans and reports, including supervising and monitoring tests
- Support homologation and product registration activities
- Participate in post market surveillance (PMS) activities and drive activities based on the conclusions from these surveillance activities
- Participate in audits and qualifications of suppliers and test houses
“We have big ambitions for the area, and you’ll be responsible for creating tools and supporting guidance documents around biological evaluation and train colleagues to lift our competencies to the next level.”
– Henrik Johanning, Head of Regulatory Affairs and your closest collaboration partner
Experienced biological evaluation expert
You are self-driven as well as highly organized and analytical. Your strong interpersonal skills give you the ability to collaborate efficiently with a variety of internal and external stakeholders. Moreover, your excellent communication skills enable you to present complex legislation clearly.
Finally, we imagine that you:
- Possess a thorough knowledge of and proven experience with chemical and biological evaluation management
- Have project management experience
- Have experience working in a regulated industry within medical devices
- Have experience with quality systems
- Are fluent in spoken and written English
- Hold a relevant master’s or bachelor’s degree within chemistry or biology
- Are able to travel up to 30 days a year to visit stakeholders globally
Would you like to know more?
To apply, use the ‘Ansøg’ link no later than March 26, 2020. 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 Regulatory Affairs Henrik Johanning on +45 4575 1585 or firstname.lastname@example.org.