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Quality Assurance Assistant

5 months ago

Bonnybridge, United Kingdom E&O Laboratories Full time

We are currently looking for an experienced Quality Assurance Assistant specialising in Regulatory Affairs to assist the Quality Manager with the Company’s regulatory compliance and processes, leading to timely product approval for both new and existing products.
This is an excellent opportunity for a person who enjoys working within quality management in a busy modern manufacturing environment.

**Responsibilities**:

- Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, IVD and other regulatory requirements.
- Act as Person responsible for regulatory compliance (PRRC) in accordance with article 15 of IVDR to ensure conformity of devices.
- Maintain regulatory databases ensuring product information is maintained.
- Take responsibility for promotion of Regulatory awareness and awareness of customer requirements across the business.
- Assist with regulatory, customer and third-party audits of the business.
- Assist with the CAPA process ensuring actions are completed in line with business deadlines.
- Ensure approved suppliers and external providers files are updated.
- Assist with continuous improvement with regard to risk management and post market surveillance.
- Assist with the QMS documentation requests both internal and external.
- Prepare internal and external reports and collate data.

**Key Skills, Qualifications and Experience**:
Bachelor’s Degree (or equivalent) in a related field with 1 years’ experience working within medical devices or IVD regulation or regulatory activities, or alternatively have 4 years’ experience working with medical devices or IVD regulation or regulatory activities.
- Knowledge of Quality Management systems, especially ISO 13485
- Be an experienced user of MS Office suite
- Have strong written and oral communication skills
- Excellent social, communication and organisational skills
- Enjoy working as part of a team in a non-corporate environment