Regulatory Affairs Technical Officer
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موقع الوظيفة:
الراتب شهرياً:
تاريخ النشر:
نُشرت قبل 23 يوم
عدد الوظائف الشاغرة:
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ملخص الوظيفة
A leading medical supplies manufacturing company based in Riyadh is seeking a Regulatory Affairs Technical Officer to support and coordinate regulatory activities and ensure compliance with SFDA FDA MDR and ISO 13485 standards. The candidate will be responsible for maintaining technical documentation and engaging with both internal quality teams and external regulatory bodies.
Responsibilities:
- Provide Level 1 and Level 2 technical support related to regulatory submissions.
- Prepare and update technical documentation (e.g. Risk Management Files Verification Reports PMS plans) in compliance with SFDA FDA MDR and ISO 13485.
- Submit regulatory files and documents to local and international authorities as required.
- Interpret and apply global regulatory frameworks to ensure full product compliance.
- Coordinate closely with the Quality Department for alignment on compliance matters.
- Draft clear and professional technical reports for both internal and external use.
- Actively support audit and inspection readiness efforts.
Requirements:
- Bachelors degree in Pharmacy Chemistry Biomedical Engineering or a related scientific or technical field.
- 01 year experience
- Quick learner.
- The company offers comprehensive training in regulatory processes and documentation standards to ensure a successful onboarding experience.
- Strong English skills in both reading and writing are essential for reviewing regulatory requirements preparing documentation and communicating with global partners.
- Effective Communication
- Time Management
- Team Collaboration
- Analytical Thinking
- Regulatory Compliance (SFDA FDA MDR ISO 13485
- Technical Documentation Preparation
- Risk Management & PostMarket Surveillance
- Audit Support & Quality Coordination
Required Experience:
Unclear Seniority
المهارات المطلوبة
- تكنولوجيا المعلومات
- السلع الاستهلاكية المعمرة
- التطبيقات
- المرافق والمنشآت
- صالة ألعاب رياضية
عن الشركة
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