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