Stuttgart-Fellbach, Germany
Senior Specialist Regulatory Affairs
You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova and Advanced Bionics, we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Advanced Bionics. Create sense.
We are looking for an European regulatory affairs team member responsible for managing pre-market and post-market regulatory approvals and activities for Advanced Bionics products EU & EFTA region, UK, the Balkan States, Ukraine, South Africa, Turkey and Russia.
You will prepare, assist and manage regulatory submissions for assigned countries and provide regulatory support in system implementation projects, post market and labelling compliance.
Furthermore, you will support as deputy “Person Responsible for Regulatory Compliance” for European Authorized Representative (PRRC-AR). Remote Work within Germany is possible.
Our Offer for your Engagement:
- Sonova and our brands offer very good perspectives and career opportunities
- Permanent contract and atmosphere of mutual trust in a highly motivated team
- Flexible working times, JobRad, attractive pay according to achievement, 30 days annual holiday
- Modern work environment and equipment
- You help to improve the quality of life of millions of people with hearing loss
- Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!
.. Main tasks and responsibilities:
- Support compliance to European Medical Device Regulation and relevant other regulations (e.g. Battery regulation, AI, Telecom etc.) in EU & EFTA region
- Country management: ensure local country compliance for EU, UK, the Balkan States, Ukraine, Turkey and Russia requirements for Class III implantable medical devices and accessories.
- Help to ensure regulatory approvals and relevant changes are achieved and maintained in accordance with business plan, as well as anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory / related teams
- Help in communication and preparation of relevant documentation to the Notified Body and National Competent Authorities plus assistance in audits by external bodies.
- Support colleagues to ensure that they are fulfilling requirements associated with Class III implantable medical devices in the countries for which responsibility is taken and maintenance of international registrations/certifications throughout the product lifecycle.
- Provide regulatory input to new product development, regulatory change assessments to Sustaining Engineering, and to project teams/RA country managers
Your profile:
- Apprenticeship in a medical field, Bachelor degree in Engineering, Biology or Medical, ideally with further education in Regulatory Affairs (e.g. RAPS, TÜV Süd Academy)
- Developed knowledge in the medical device field, 5+ years experience of working in the medical device field in the regulatory affairs department
- Strong writing and data management skills and basic understanding of Class III medical device labeling requirements
- willingness to travel up to (20%)
- English: excellent written/oral communication skills
- IT skills: Microsoft Office, ideally knowledge of some statistics software.
In return, we offer an exciting and challenging position with great potential for personal development, with a unique organization in a fascinating and fast-growing medical industry. If you want to work in an enthusiastic, motivated team and help launch the hearing implants of the future then send us your online application in English. We favour disabled applicants over non-disabled applicants if they have the same qualification.
For this vacancy only direct applications will be considered.
Advanced Bionics GmbH
Max-Eyth-Str. 20
70736 Fellbach
+49 711 51070 371
www.advancedbionics.com
Create impact. Transform lives – sonova.com/careers