Regulatory Affairs / R&d Manager (m/w/d)

HARTMANN

Sontheim am Brenz, Germany
On-site
Product safety and conformity
Technical product and packaging solutions
Regulatory support for development projects
Take responsibility for regulatory processes to ensure product safety and conformity across the entire product range

Job Summary

  • Take responsibility for regulatory processes to ensure product safety and conformity across the entire product range.
  • Develop technical product and packaging solutions for medical devices and personal protective equipment, considering regulatory requirements.
  • We offer 30 days of vacation per year, a personal working time account, special leave for exceptional life events, vacation pay, and an annual special payment according to the collective agreement.

Matching Summary

Take responsibility for regulatory processes to ensure product safety and conformity across the entire product range.

Skills & Requirements

Must-have

  • Product safety and conformity
  • Technical product and packaging solutions
  • Regulatory support for development projects
  • Legal and regulatory compliance
  • Customer inquiry resolution

Nice-to-have

  • Interdisciplinary collaboration
  • Conceptual thinking
  • Adaptability to complex contexts

Key Requirements

  • Degree in Medical Technology or comparable technical/scientific field
  • Further training in Regulatory Affairs or related regulatory topics
  • Experience with medical devices
  • Knowledge of international approval procedures (MDR, FDA, ISO 13485)
  • Very good German and English skills

Work Rights

Not specified

Tailored Resume

Cover Letter