Country Expert – Drugs Pre & Post Market & Supply Chain Quality
Fresenius Medical Care · Praha 6
Job description
About the role
As a Country Expert for Drugs Pre & Post Market & Supply Chain Quality, you will ensure that healthcare products are compliant, safe, and continuously available in the market. You will act as the primary regulatory liaison between local operations, global teams, and authorities, overseeing the full product lifecycle.
Key responsibilities
- Serve as the main regulatory contact for authorities and internal stakeholders.
- Manage regulatory activities across the product lifecycle, including market authorizations, submissions, and updates.
- Handle adverse events and ensure compliance with internal and GVP requirements.
- Act as the GDP Qualified Person, maintaining QMS, recall, training, SOP and CAPA processes in line with GDP and distribution requirements.
- Monitor regulatory changes and ensure adherence to local legislation and internal SOPs.
- Review marketing materials for regulatory compliance.
- Support audits and inspections, including CAPA implementation.
- Collaborate cross‑functionally to guarantee product quality, compliance, and supply continuity.
- Provide support across multiple countries as needed.
Required profile
- University degree in Life Sciences or a related field.
Required skills
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Published před 1 měsícem
Expires za 3 týdny
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Fresenius Medical Care
Praha 6