Quality Assurance and Regulatory Affairs Specialist
4 weeks ago
Job Title:
QARA Executive
Job Purpose:
A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector.
Roles & Responsibilities:
- Apply technical solutions to problem solving and quality improvement projects.
- Use technical writing skills to clearly describe technical information.
- Analyze customer complaints, identify trends, and execute corrective actions.
- Understand standards and their application to medical devices.
- Planning, protocol generation, testing, and report generation for medical devices.
- Generation and maintenance of technical files for medical devices.
- Review and update technical files in line with EU medical devices regulatory requirements.
- The use of harmonised standards when compiling a technical file in compliance with the MDD.
- Ensuring that records are filed in accordance with site procedures.
- Supporting R&D.
Education and Experience:
- Engineering / Science qualification.
- 3 - 7 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment.
- Excellent technical writing experience within a medical device environment.
- 3 - 7 years experience in Risk, Clinical, and Biocompatibility an advantage.
- Must have knowledge of ISO 13485.
- Must have Skills: - USFDA, ISO 13485, ISO 9001, Product Development, Capa, Quality Assurance, Process Excellence, Six Sigma Black Belt, Project Management, CDSCO, MDD/MDR, Clinical, PMP.
Skills:
- Strong communication skills.
- Ability to work well under pressure.
- Attention to detail.
- A desire to keep learning.
- Flexibility.
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