About this role
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