Quality Assurance and Regulatory Affairs Assistant
2 months ago
**Role**: Quality Assurance and Regulatory Affairs Assistant
**Salary**:Extremely competitive basic salary plus annual bonus
**Location: Bethesda, Bangor**
Our client, a leading global Medical Device company, is currently seeking a Quality Assurance and Regulatory Affairs Assistant to join their team.
This is a fantastic opportunity to join an extremely successful and forward-thinking company, for an experienced individual who is eager to develop their career.
Reporting to the QA/RA Manager, this job role is to support the Quality and Regulatory Team by assisting with policies on quality standards and regulatory compliance; and assisting with the execution of the Quality Team duties.
**Essential Job Functions**
- Inspecting, verifying and maintaining compliance documentation including responsibility for the document control system.
- Supporting the design and maintenance of the Quality System
- Maintaining supplier, distributor, and customer communications and records
- Complying with all safety policies, practices and procedures
- Supporting the monitoring and measuring activities, including NCRs, CAPAs, and Customer Complaints
- Key participant within the QA/RA team in the execution of their duties.
- Risk Management Team Member
- Assist with the review of documentation
**Qualifications**:
- Previous experience in QA/RA
- Strong attention to detail
- Proficient in Microsoft packages
- ISO 9001 experience
- EU, UK medical device regulation training an advantage, but not essential.
**Job Types**: Full-time, Permanent
**Benefits**:
- Company pension
- On-site parking
Schedule:
- Monday to Friday
Supplemental pay types:
- Performance bonus
- Yearly bonus
**Experience**:
- Quality assurance: 1 year (required)
Work Location: In person
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