Advanced Bionics | Clinical Research
Germany or UK - Full remote or Hybrid in Hannover office
At Advanced Bionics, a Sonova brand, we are passionate about transforming lives through innovative hearing solutions. As a Senior Clinical Evaluation Specialist, you will play a key role in generating and communicating clinical evidence that supports the safety, performance, and regulatory compliance of our cochlear implant technologies.
Your Responsibilities
- Independently author and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, and PMCF documentation
- Conduct systematic literature reviews, including evidence appraisal and data synthesis
- Identify clinical evidence gaps and recommend appropriate data generation strategies
- Support regulatory submissions and responses to Notified Bodies and regulatory authorities
- Plan and execute PMCF activities, including study coordination, data analysis, and reporting
- Collaborate with Regulatory Affairs, Clinical Research, Quality, and other cross-functional stakeholders
- Ensure all clinical evaluation deliverables meet the highest scientific and regulatory standards
What You Bring
- Master's degree in a clinical or life sciences field such as Audiology, Biomedical Engineering, Medicine, Pharmacy, Nursing, Public Health, or a related discipline
- At least 2 years of experience in clinical evaluation, medical writing, or clinical research within the medical device industry
- Proven experience authoring Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)
- Strong knowledge of systematic literature reviews, clinical evidence appraisal, and scientific writing
- Excellent analytical skills with the ability to interpret and synthesize clinical data
- Strong organizational skills and the ability to manage multiple priorities independently
- Fluent English communication and scientific writing skills
What We Offer
- The opportunity to contribute to life-changing hearing technologies
- A collaborative and international working environment
- Exposure to innovative research and cutting-edge medical devices
- Flexible working arrangements and opportunities for professional development
- A culture that values ownership, scientific excellence, and continuous learning #LI-NB1
Senior Clinical Evaluation Specialist (m/f/d) Arbeitgeber: Sonova International
Als einer der weltweit führenden Anbieter im Bereich Hörgesundheit mit Sitz in der Schweiz, bieten wir Ihnen die Möglichkeit, in einem dynamischen und kollaborativen Umfeld zu arbeiten, das hohe Autonomie und Vielfalt in den Produkten und Märkten bietet. Wir fördern eine inklusive Unternehmenskultur, die es Ihnen ermöglicht, Ihre beruflichen Ziele mit Ihren persönlichen Interessen in Einklang zu bringen, unterstützt durch ein flexibles hybrides Arbeitsmodell und zahlreiche Entwicklungs- und Wachstumschancen.
