In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Staefa, Switzerland
In this challenging position, your main task will be to support the country product registrations worldwide (outside the Americas) as well as the general product registrations according to the regulatory requirements for Active Implantable Medical Devices.
Your tasks
• International submissions (outside of the US) to obtain approvals to commercially distribute products
• Maintenance of international registrations/certifications throughout the product lifecycle
• Maintenance of regulatory technical documentation for entire product portfolio
• Compilation and maintenance of the regulatory documents necessary to support submissions, renewals and tenders
• Support periodic external reporting
• Assist in the research and dissemination of regulatory intelligence topics
• Support the Regulatory Affairs management and team with necessary tasks
Your profile
• Minimum Bachelor degree in Engineering, Biology, Medical or related field of study
• At least 3 years of practical experience in the field of Regulatory Affairs or Quality Assurance (related to product development
would be an asset)
• Experience in dealing with international product registrations in a medical device company
• Motivated team player who thrives in a collaborative work environment with excellent interpersonal, communication and
organizational skills
• Flexible and adaptable to changing priorities including helping others with projects as needed, and asking for help when needed to
maintain the project schedule
• Very good English skills, German and other languages are an asset
Our offer
We can offer you a new challenge, with interesting tasks and much more – including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.
Jennifer Hofmann, Human Resources Manager, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.
Advanced Bionics AG
Laubisrütistrasse 28
CH-8712 Stäfa
+41 58 928 01 01
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.