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ST
Stryker
3d ago

Senior Clinical Affairs Specialist(m/w/x)

Freiburg im Breisgau
Full-timeOn-siteSenior

Description

As a technical expert in Freiburg, you will lead the clinical evaluation process for innovative medical devices, ensuring product safety and regulatory compliance throughout their entire lifecycle.

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Requirements

  • •University degree in life sciences, medical engineering, or equivalent
  • •Several years of clinical or academic research experience
  • •Proven medical or scientific writing experience
  • •Experience in data analysis and statistics
  • •Experience in a regulated environment preferred
  • •Knowledge of Clinical Evaluation regulations preferred
  • •Experience with clinical study design and analysis
  • •Independent work, decision-making, and project leadership
  • •Excellent communication and stakeholder-management skills
  • •Strong analytical mindset for scientific data
  • •Proactive, collaborative, and international teamwork skills
  • •Full professional English proficiency and German fluency

Education

Master's degree

Work Experience

approx. 4 - 6 years

Tasks

  • •Lead the clinical evaluation process
  • •Develop and update CEP, CER, SSCP, and PMCF deliverables
  • •Perform complex literature reviews and analyze medical trends
  • •Develop sustainable literature search strategies
  • •Manage clinical evidence strategies during product development
  • •Align clinical goals with marketing and regulatory strategies
  • •Define and defend clinical strategies for international approvals
  • •Support new product development and post-market surveillance
  • •Provide expert clinical guidance to cross-functional teams
  • •Refine clinical evaluation methodologies to meet evolving regulations

Tools & Technologies

MEDDEV 2.7/1 Rev. 4EU MDRMDCGTGA

Languages

English – Business Fluent

German – Business Fluent

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