Regulatory Clinical Affairs Specialist

vor 7 Monaten

Hannover, Deutschland Sonova Vollzeit

Who we are

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 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 Sonova. Create sense.
- Hannover, GermanyRegulatory Clinical Affairs Specialist (M/F/d)
- 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.- In Hanover, Germany, Advanced Bionics runs the European Research Center (ERC), founded in 2009. The ERC coordinates research and technology as well as regulatory clinical affairs activities in Europe. The ERC works in close cooperation with European clinics, technology providers and universities.**Our Offer for your Engagement**:

- Sonova and our brands offer very good perspectives and career opportunities
- Atmosphere of mutual trust in a highly motivated team
- Flexible working times, JobRad, attractive pay according to achievement, 30 days annual holiday, remote working passible (within Europe)
- Modern work environment and equipment
- You help to improve the quality of life of millions of people with hearing loss

**Main tasks and responsibilities**:

- Ensure compliance with Medical Device Regulation (MDR) requirements to obtain and sustain product approval by TÜV: Post-Market Clinical Follow-up and support of Clinical Evaluation documentation
- Ensure departmental processes comply to regulations and standards (e.g. EU MDR, ISO 14155)
- Support and conduct pre
- and post
- market clinical studies to obtain and sustain product approval by TÜV

**Your profile**:

- Master in a scientific domain such as biomedical engineering, physics, audiology
- Training on regulatory clinical requirements: in depth knowledge of EU MDR and ISO 14155
- Minimum 2 years of experience in regulatory clinical affairs for medical devices ideally for class III devices or in the auditory implant domain
- Willingness to travel internationally (20%)
- English: excellent written/oral communication skills; fluency in one or more additional European language(s) ideally French
- IT skills: Microsoft Office, ideally knowledge of some statistics software.- Advanced Bionics GmbH- Max-Eyth-Str. 20- 70736 Fellbach- +49 711 51070 371
Sonova is an equal opportunity employer

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