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- Tasks: Ensure compliance with quality standards and regulatory requirements in a dynamic biotech environment.
- Company: Join a growing Biotechnology company based in Newcastle with significant growth potential.
- Benefits: Gain hands-on experience in quality assurance and regulatory affairs with a supportive team.
- Why this job: Be part of a culture that values quality and continuous improvement while making a real impact.
- Qualifications: Bachelor’s degree in Life Science and experience in quality assurance or regulatory affairs required.
- Other info: Opportunity to work cross-functionally and lead training sessions for a quality-centric culture.
The predicted salary is between 36000 - 60000 £ per year.
CY Partners Recruitment is delighted to be partnering with growing Biotechnology company based in Newcastle with their search for a Quality Assurance/Regulatory Affairs (QARA) Officer.
Reporting to the QARA Manager in this key role you will ensure compliance with quality standards, regulatory requirements and best practice within the organisation.
This is an exceptional role for someone who is looking to take a step into a dynamic environment, with projected significant growth for the organisation and the post-holder.
Main Duties and Responsibilities
– Document Control – responsible for the document control system ensuring accurate and up to date records of procedures and quality related documents.
– Corrective and Preventative Actions (CAPA) – overseeing the CAPA process which involves identifying and addressing issues, deviations and non-conformities to improve product quality and compliance.
– Change Management – coordinating changes to processes, products or systems while maintaining quality standards.
– Technical Files – working with the quality team to create and update product technical files.
– Develop, implement, and manage quality systems designed to ensure continuous production/service that meets established standards and customer specifications.
– Perform routine inspections to verify compliance with company and regulatory requirements.
– Analyse data to identify areas for improvement in the quality system including troubleshooting product or process failures.
– Coordinate with operations and development teams to ensure quality standards are understood and integrated in all areas.
– Facilitate corrective actions and improvement strategies for non-conformances and quality issues identified during internal and external audits
– Lead training sessions for staff on quality assurance processes, tools and standards to foster a quality-centric culture within the organisation.
– Support the internal audit process and preparation for notified body audits.
– Follow company quality procedures and promote quality practises within the organisation.
– Support update of QMS for IVDR
– Be proactive and show initiative regarding time management, work prioritisation and committing to time-critical tasks
– Work cross functionally with other teams and functions across the business
– Involvement in risk management
To be considered for the role of QA/RA Officer, you’ll need the following qualifications, skills and experience:
– Bachelor’s degree or equivalent experience in a Life Science subject.
– Experience in quality assurance and regulatory affairs within the medical device, pharmaceutical or related industry.
– Possess a knowledge and understanding of Quality Management Systems (QMS) and standards and regulations according to ISO 13485 and IVDR or similar.
– Knowledge of NC/CAPA investigations.
– Excellent attention to detail regarding existing and new documentation.
– Experience or knowledge of IVD medical devices and Quality Systems.
– Positive, team-focused approach to working and problem-solving.
– Competent with Microsoft Word, Excel, PowerPoint and SharePoint.
Location – The role is to be primarily based at the site in the Newcastle upon Tyne.
Application Instructions:
Please apply online here –
CY Partners is acting as an Employment Business / Agency in relation to this vacancy.
Quality Assurance/Regulatory Affairs Officer employer: CY Partners
Contact Detail:
CY Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance/Regulatory Affairs Officer
✨Tip Number 1
Familiarize yourself with the specific quality standards and regulations mentioned in the job description, such as ISO 13485 and IVDR. This knowledge will not only help you understand the role better but also demonstrate your commitment to quality assurance during the interview.
✨Tip Number 2
Highlight any experience you have with document control systems and CAPA processes. Be prepared to discuss specific examples of how you've contributed to improving product quality and compliance in your previous roles.
✨Tip Number 3
Showcase your ability to work cross-functionally by preparing examples of past collaborations with different teams. This will illustrate your team-focused approach and problem-solving skills, which are essential for this position.
✨Tip Number 4
Research the company’s recent developments and growth projections. Being knowledgeable about their current projects and future goals will allow you to tailor your responses and show genuine interest during the interview process.
We think you need these skills to ace Quality Assurance/Regulatory Affairs Officer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Assurance/Regulatory Affairs Officer position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in quality assurance and regulatory affairs, particularly within the medical device or pharmaceutical industries. Mention specific projects or achievements that demonstrate your expertise.
Showcase Your Skills: Clearly outline your knowledge of Quality Management Systems (QMS) and relevant standards such as ISO 13485 and IVDR. Provide examples of how you've applied these skills in previous roles.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your enthusiasm for the role and the company. Make sure to convey your proactive approach and team-focused mindset.
How to prepare for a job interview at CY Partners
✨Understand Quality Management Systems
Make sure you have a solid grasp of Quality Management Systems (QMS) and relevant standards like ISO 13485 and IVDR. Be prepared to discuss how you've applied these in your previous roles or how you would approach implementing them in this new position.
✨Showcase Your Attention to Detail
Since the role requires excellent attention to detail, come ready with examples that demonstrate your meticulousness. Discuss specific instances where your attention to detail made a significant impact on quality assurance or regulatory compliance.
✨Prepare for CAPA Discussions
Familiarize yourself with the Corrective and Preventative Actions (CAPA) process. Be ready to explain how you've identified issues and implemented corrective actions in past experiences, as well as how you would handle similar situations in this role.
✨Emphasize Team Collaboration
This position involves working cross-functionally with various teams. Highlight your experience in collaborative environments and provide examples of how you've successfully worked with others to achieve quality goals or resolve issues.
