Global Regulatory Affairs RF Specialist Quality · Lynge, Copenhagen Region, Denmark
WS Audiology Denmark A/S
Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.
The external requirements to the medical device industry are increasing and we are a Global Group Regulatory Affairs team of approx. 10 persons who facilitate and actively participate in ensuring that WSA adheres to the right standards of compliance. This position belongs to a HQ function and it is important to manage both HQ and global stakeholders, so they feel confident in the advice and support they get from Global Regulatory Affairs.
What you will do
- Consultancy support to Project Managers and technical experts in WSA R&D within the discipline of Regulatory Affairs for Medical Devices which contain wireless technology
- Regulatory Affairs support to WSA R&D projects about RF, EMC and Electrical Safety plus Medical Device regulations
- Optimization of global test strategies in close collaboration with R&D
- Supporting RF Registration of products in EMEA and Americas through local affiliates
- Support surveillance activities of relevant technical standards and maintenance of the companies standard surveillance system
- Participation in International standardisation working groups if needed to represent the interest of WSA
- Monitor national certification processes and requirements for RF submissions to Authorities in agreed countries
What you bring
Experience
- Consultancy support to Project Managers and technical experts in WSA R&D within the discipline of Regulatory Affairs for Medical Devices which contain wireless technology
- Regulatory Affairs support to WSA R&D projects about RF, EMC and Electrical Safety plus Medical Device regulations
- Optimization of global test strategies in close collaboration with R&D
- Supporting RF Registration of products in EMEA and Americas through local affiliates
- Support surveillance activities of relevant technical standards and maintenance of the companies standard surveillance system
- Participation in International standardisation working groups if needed to represent the interest of WSA
- Monitor national certification processes and requirements for RF submissions to Authorities in agreed countries
- Project management skills would be beneficial
What we would like to offer you
Lynge:
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.
Erlangen:
Who we are
At WS Audiology, we provide innovative hearing aids and hearing health services.
Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.
With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.
Sounds wonderful? We can't wait to hear from you.
WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.
Department
Quality
Role
Group Quality - Regulatory Affairs
Locations
Lynge, Copenhagen Region, Denmark
Contact Diana Heindl-Kraus Talent Acquisition Partner – Human Resources
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