Every day our 12,500 colleagues in 130 markets help millions of people regain and benefit from the miracle of hearing. Going beyond together, we achieve annual revenues of around EUR 2.3 billion. Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations.
A bit about the role
We are looking for a Product Risk Manager for our R&D area, with a background in quality management system to join our global product risk management team.
You will work with a R&D department of +1000 people on everything from development on hearing aids, accessories for hearing aids as well as our Software systems. You will be working across our three R&D consisting of Singapore, Erlangen (Germany) as well as Lynge, Denmark.
You will be based out of our HQ in Lynge, Denmark.
You will be responsible for the following:
- Product Risk Manager for WS Audiology product in accordance to ISO14971:2019
- Support of risk management activities for WSA including risk management process/ risk assessment for R&D
- Involve in Production and Post-Production Information as part of Post Market Surveillance System
- Role of Product Risk Manager for R&D development projects in Singapore, Erlangen and Lynge including hardware, software and accessories
- Support product risk management related audits (Customer, internal and external)
A bit about you
We are looking for someone who are motivated by the notion of impacting one of the significant areas within our company and help ensuring that we develop the best possible products. Furthermore, you have good communication skills as well as the skills to interact and drive progress across all types of stakeholders.
Furthermore, we expect you to have the following experience:
- 3-5 years of experience in risk management / quality management domain in the medical device / manufacturing industry
- QSR, MDR, MDD, ISO 13485, ISO 14971
- US FDA inspection and ISO 13485 audit experience
- Added advantage to have regulatory affairs knowledge/ experience
What we would like to offer you
The working environment at WS Audiology is informal but we are result-oriented and focus on creating the best possible products and services. You can expect a working culture with a large degree of freedom under responsibility.
Our values focus on teamwork across functions, pioneering for better solutions, and the passion to make an impact. So, if you can see yourself in those values, you will fit right in.
The benefits we can offer include an advantageous pension scheme with health insurance, sports and arts club, and good canteen facilities.
Our Danish headquarter is based in a CO2 neutral and modern facility with beautiful surroundings in Lynge, close to Allerød, north of Copenhagen, Denmark.
Sounds Wonderful? Join us
Send your CV, no application needed, as soon as possible. We will review and invite candidates for interview on an ongoing basis.