Clinical research associate Jobs in Saarbrücken
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Clinical research associate • saarbrucken
Senior Quality & Regulatory Affairs Manager
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WELOCALIZE GMBHSaarbrücken, Saarland, GermanySenior Quality & Regulatory Affairs Manager
ki elementsSaarbrücken, Saarland, Germanyki : elements pioneers speech-based biomarkers as tools for clinical research. We are looking for a Quality & Regulatory Lead to bridge the gap between our agile company and the rigorous demands of global clinical trials .
Regulatory excellence is central to our operations. Reporting directly to the CEO you will own our compliance roadmap shape our regulatory strategy refine our QMS and ensure our technology meets the highest standards for both FDA / EMA and our global pharma partners.
Tasks
- Lead the roadmap development and management for key certifications specifically FDA 510(k) clearance and EU MDR.
- Ensure our technology aligns with clinical trial requirements including 21 CFR Part 11 and GCP / GxP standards.
- Oversee our QMS (ISO 13485 / ISO 27001).
- Manage and mentor the existing RA / QA staff. You will set priorities review technical documentation and foster a culture of Compliance by Design.
- Act as the primary point of contact for external audits and stringent technical assessments from pharmaceutical partners.
Requirements
Benefits
If our profiles match we would be delighted to hear from you.
Key Skills
Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Employment Type : Employee
Experience : years
Vacancy : 1
Yearly Salary Salary : 73000 - 92000