Senior Clinical Evaluation Specialist (m/f/d)

Sonova Group; Hannover; Hybrid; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Sonova, including Advanced Bionics, is seeking a Senior Clinical Evaluation Specialist to generate clinical evidence supporting safety, performance, and regulatory compliance of cochlear implant technologies. The role emphasizes CEP/CER authoring, PMCF planning, and collaboration with cross-functional teams.

The ideal candidate holds a Master's in a clinical or life sciences field, with 2+ years in clinical evaluation or medical writing within medical devices, and fluent English communication.

Qualifikationen

• Master's degree in a clinical or life sciences field.
• At least 2 years of experience in clinical evaluation, medical writing, or clinical research within the medical device industry.
• Proven experience authoring CEP and CER.
• Fluent English communication and scientific writing.

Aufgaben

• Author and maintain Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER).
• Prepare SSCPs and PMCF documentation.
• Conduct systematic literature reviews and evidence appraisal.
• Identify evidence gaps and propose data generation strategies.
• Support regulatory submissions and responses to Notified Bodies.
• Coordinate PMCF activities and data reporting.
• Collaborate with Regulatory Affairs, Clinical Research, Quality, and cross-functional teams.

Kenntnisse

Analytical skills

Scientific writing

Systematic literature reviews

Clinical evaluation

Ausbildung

Master's degree in clinical or life sciences

Jobbeschreibung

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Greater London, United Kingdom

Senior Clinical Evaluation Specialist (m/f/d)

164679

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

Sonova is an equal opportunity employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

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