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About the Role
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.
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
Requirements
- 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
Skills
- Clinical Evaluation
- Medical Writing
- Clinical Research
- Systematic Literature Reviews
- Scientific Writing
- Analytical Skills
- Organizational Skills
- English Communication
Location
- Germany
- UK
Work Type
- Full remote
- Hybrid
Experience Level
- Senior
Education Level
- Master's degree in a clinical or life sciences field
Benefits
- 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
About the Company
- Advanced Bionics, a Sonova brand, is passionate about transforming lives through innovative hearing solutions.