Senior Clinical Evaluation Specialist (m/f/d)

Sonova
London, Hannover
Workplace: HybridFull timeFunction: Solutions Engineering & Sales EngineeringEducation: mastersSkills: ["Independent authoring","Analytical skills","Organizational skills","Scientific writing","Prioritization"]

Independently create and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, and PMCF documentation to build and communicate clinical evidence for cochlear implant technologies. Conduct systematic literature reviews, identify evidence gaps, and propose data generation strategies. Support regulatory submissions and Notified Body responses, and plan PMCF activities including study coordination, data analysis, and reporting in collaboration with cross-functional teams.

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FursaFursa
Sonova
Sonova
22 hours ago

Senior Clinical Evaluation Specialist (m/f/d)

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Source: Company careers pageValidated by: Fursa AI
Last checked: 8 hours agoStatus: Live

Job Summary

Independently create and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, and PMCF documentation to build and communicate clinical evidence for cochlear implant technologies. Conduct systematic literature reviews, identify evidence gaps, and propose data generation strategies. Support regulatory submissions and Notified Body responses, and plan PMCF activities including study coordination, data analysis, and reporting in collaboration with cross-functional teams.
Location: London, Hannover
Workplace: Hybrid
Employment Type: Full time
Job Function: Solutions Engineering & Sales Engineering
Seniority: Mid level

Key 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 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, in collaboration with cross-functional stakeholders.

Key Requirements

  • •Master’s degree in a clinical or life sciences field (e.g., Audiology, Biomedical Engineering, Medicine, Pharmacy, Nursing, Public Health) or related discipline.
  • •At least 2 years of experience in clinical evaluation, medical writing, or clinical research in 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.
  • •Fluent English communication and scientific writing skills.
Experience:Medical device industry
Education:Master's in clinical or life sciences (e.g., Audiology, Biomedical Engineering, Medicine, Pharmacy, Nursing, Public Health)
Skills:Independent authoringAnalytical skillsOrganizational skillsScientific writingPrioritization
Languages:English

Company Brief

Sonova
Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Stäfa, Switzerland
Founded: 1947
Website