Clinical Affairs Manager

vor 1 Tag

Munich, Bayern, Deutschland LUKA GLOBAL Vollzeit

A pioneering digital health company is looking for a Clinical Affairs Manager to lead clinical strategy and operations to ensure scientific rigor, regulatory compliance and meaningful clinical impact across studies and collaborations.

You will be responsible for designing, executing, and managing clinical validation and intervention studies, supporting regulatory submissions and building relationships with key clinical, corporate, and academic partners.

Key Responsibilities:

  • Lead the design, implementation, and management of clinical trials and observational studies.
  • Coordinate with investigators, CROs, and internal teams to ensure data quality, compliance and timely delivery.
  • Support regulatory submissions (FDA, MDR, CE) and collaborate with quality teams to maintain audit readiness.
  • Build and manage collaborations with hospitals, clinicians and research institutions.
  • Translate clinical and real-world data into evidence for publications, white papers and medical communications.
  • Provide clinical insights to guide product development, usability and go-to-market strategy.

Candidate Profile

  • Advanced degree in life sciences, biomedical engineering, nursing, or related field (PhD, MD, MSc, or equivalent)
  • Proven experience managing clinical studies in digital health, medical devices or connected technologies
  • Knowledge of GCP, ISO 14155 and regulatory frameworks (FDA, MDR)
  • Strong project management, collaboration and communication skills
  • Experience in neurology, movement disorders, digital biomarkers or SaMD is desirable
  • Strong language skills in English and German

Role Highlights

  • Shape the future of neurological care through cutting-edge digital health innovation
  • Work at the intersection of AI, clinical science and real-world patient care
  • Competitive compensation, equity and benefits
  • Flexible, inclusive and intellectually stimulating culture

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