Global Regulatory Affairs RF Specialist
Found in: Talent DK C2 - 2 weeks ago
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 technologyRegulatory Affairs support to WSA R&D projects about RF, EMC and Electrical Safety plus Medical Device regulationsOptimization of global test strategies in close collaboration with R&DSupporting RF Registration of products in EMEA and Americas through local affiliatesSupport surveillance activities of relevant technical standards and maintenance of the companies standard surveillance systemParticipation in International standardisation working groups if needed to represent the interest of WSAMonitor national certification processes and requirements for RF submissions to Authorities in agreed countriesWhat 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 technologyRegulatory Affairs support to WSA R&D projects about RF, EMC and Electrical Safety plus Medical Device regulationsOptimization of global test strategies in close collaboration with R&DSupporting RF Registration of products in EMEA and Americas through local affiliatesSupport surveillance activities of relevant technical standards and maintenance of the companies standard surveillance systemParticipation in International standardisation working groups if needed to represent the interest of WSAMonitor national certification processes and requirements for RF submissions to Authorities in agreed countriesProject management skills would be beneficialWhat 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:
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