Drug Quality & Regulatory Expert – Pre & Post‑market (spain)

Fresenius Medical Care

Spain
**
Regulatory submissions and filings experience
Gdp compliance and post-market surveillance
Iso 9001 and iso 13485 knowledge
** Fresenius Medical Care is seeking a Drug Quality & Regulatory Expert for its Spain location, focusing on pre and post-market compliance within the pharmaceutical sector. The role requires expertise in regulatory affairs, pharmacovigilance, and quality assurance to ensure adherence to national and international regulations throughout the medication lifecycle. **

Job Summary

  • The role ensures the entire lifecycle of medication from registration through post-marketing surveillance complies with national and international regulations.
  • Fresenius Medical Care is a global leader in kidney care committed to improving patient lives with over 125,000 employees worldwide.
  • The position offers individual opportunities for self-determined career planning within a corporate culture that values innovative thinking and diversity.

Matching Summary

Match Score: 75

** Fresenius Medical Care is seeking a Drug Quality & Regulatory Expert for its Spain location, focusing on pre and post-market compliance within the pharmaceutical sector. The role requires expertise in regulatory affairs, pharmacovigilance, and quality assurance to ensure adherence to national and international regulations throughout the medication lifecycle. **

Skills & Requirements

Must-have

  • Regulatory submissions and filings experience
  • GDP compliance and post-market surveillance
  • ISO 9001 and ISO 13485 knowledge
  • Pharmacovigilance regulations expertise
  • MedTech or Pharma industry background

Nice-to-have

  • Hybrid work arrangement availability
  • Additional language proficiency
  • Innovative thinking culture fit
  • Global team collaboration skills

Key Requirements

  • Minimum BA degree in Pharmacy or related field
  • 2-4 years experience in regulatory affairs
  • 2 years experience in MedTech/Pharma industry
  • 2 years experience in regulatory submissions
  • 2 years experience in GDP-related activities
  • 1 year experience in pharmacovigilance

Work Rights

Not specified

Tailored Resume

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