Quality Assurance and Regulatory Affairs Assistant

2 months ago


Bethesda, United Kingdom Westcott Search Full time

**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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