Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful.
We are active in over 125 markets, and employ more than 11,000 people worldwide. Our broad portfolio of leading hearing related products and services generates annual revenues of more than € 1.7 Billion.
As a global leader, our ambition is to unlock human potential by making wonderful sound part of everyone’s life.
Learn about us on www.wsa.com
As Regulatory Affairs Professional you will be part of the Global Quality Regulatory Affairs team. The team supports the entire organization, and you will play a critical role when supporting R&D/Marketing during the develop process and when evaluating EU potential vigilance cases for reportability. You will be involved in a broad range of tasks related to the Medical Device Regulations in Europe:
- Support the R&D function with questions about product classification, standards, intended use of the product, regulatory strategy and labeling.
- Prepare and sign Declaration of Conformity in close cooperation with Lynge RA
- Evaluate EU potential vigilance cases for reportability and registration in the Eudamed database.
- Regulatory problem solving to ensure compliance with regulations and standards
Modern hearing solutions are technical complex, and you will become part of an experienced RA team who will support you in your professional development.
You will report to our Senior Director Regulatory Affairs.
You most likely fit the following profile:
- University degree in the field of Technical Engineering, Quality Engineering, Pharmacy or similar
- High energy level
- Motivated towards Regulatory Affairs
- Team Player
- Flexible working style
- Independently and taking over initiative
- Good communication skills
- Ability to learn fast
- Strong Process Management skills
- Good ability to analyze
Our corporate language is English, so you need to be confident in English, both verbally and in writing.
What we offer
We are driven by innovation and development so working with us is a constant learning curve. You will be located in our site in Erlangen, Germany with dynamic and progressive colleagues, who are highly skilled and empathetic.
We offer flexible working times & opportunities for working from home. You can always get free coffee at the office and visit the subsidized cafeteria for a rich variety of lunch options. We are part of the IG Metall tariff agreement offering attractive compensation and futher benefits like contributions to the company pension plan or child-care.
Join WS Audiology
If this opportunity sounds interesting to you, please submit your application stating your earliest starting date and your salary expectations and we will get back to you as soon as possible.