Senior Clinical Evaluation Specialist (m/f/d) (Hannover, Germany)

Sonova
Hannover
Workplace: OnsiteFull timeFunction: Solutions Engineering & Sales EngineeringExperience: 2+ yearsEducation: mastersSkills: ["Scientific writing","Analytical skills","Organizational skills","Evidence appraisal","Cross-functional collaboration"]

Generate and communicate clinical evidence for cochlear implant technologies by authoring and maintaining Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, and PMCF documentation. Conduct systematic literature reviews, appraise and synthesize evidence, and identify evidence gaps to recommend data generation strategies. Support regulatory submissions and responses to Notified Bodies, and plan and execute PMCF activities while collaborating with cross-functional teams to meet scientific and regulatory standards.

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FursaFursa
Sonova
Sonova
1 month ago

Senior Clinical Evaluation Specialist (m/f/d) (Hannover, Germany)

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Last checked: 3 hours agoStatus: Live

Job Summary

Generate and communicate clinical evidence for cochlear implant technologies by authoring and maintaining Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, and PMCF documentation. Conduct systematic literature reviews, appraise and synthesize evidence, and identify evidence gaps to recommend data generation strategies. Support regulatory submissions and responses to Notified Bodies, and plan and execute PMCF activities while collaborating with cross-functional teams to meet scientific and regulatory standards.
Location: Hannover
Workplace: Onsite
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 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, 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.
  • •Excellent analytical skills to interpret and synthesize clinical data, with strong organizational skills and fluent English scientific writing.
Experience:2+ yearsMedical device industry
Education:Master's
Skills:Scientific writingAnalytical skillsOrganizational skillsEvidence appraisalCross-functional collaboration
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