Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Support the Quality Manager in ensuring compliance and quality assurance processes.
- Company: Join Meditech, a leading British Medical Equipment Manufacturer making a difference in healthcare.
- Benefits: Enjoy a collaborative office environment with opportunities for professional growth.
- Why this job: Be part of a vital team impacting patient care and safety in the medical field.
- Qualifications: Bachelor's degree in a relevant field or 4 years' experience in QA/RA roles required.
- Other info: Ideal for those passionate about quality in medical devices and eager to learn.
The predicted salary is between 30000 - 42000 £ per year.
Meditech is an internationally recognised British Medical Equipment Manufacturer specialising in Medical Gas equipment for Hospitals and the Emergency services, based in Halstead, Essex, UK. The company has seen an unprecedented level of demand for its Medical Oxygen products throughout the COVID-19 period, particularly by the NHS. There has been an enormous amount of investment in machinery and manufacturing equipment recently and the company has many new skilled staff working in specialist areas. Another critically important team member is urgently required.
The Quality and Regulatory Assistant's role is responsible for supporting the Quality Manager with the organisation's quality assurance processes and ensuring compliance with industry regulations. This role requires a strategic approach to ensuring that the company’s products, services, and operations meet both customer expectations and legal requirements. The ideal candidate will preferably be experienced in ISO 13485:2016, EU Medical Device Regulations (MDR) 2017/745 and UK MDR 2002. Knowledge of Class IIa and IIb medical device technical documentation requirements is beneficial.
Key Responsibilities:
- Quality Assurance & Control: Maintain the company’s Quality Management system (ISO 13485:2016 QMS) to ensure adherence to industry standards. Conduct internal quality audits to evaluate compliance with established quality standards, identify areas for improvement and follow up on corrective actions. Manage the lifecycle of the medical device, from initial design to placing product on the market.
- Regulatory Compliance: Prepare technical file submissions, and responses for regulatory inspections to the EU Medical Device Regulations (MDR) 2017/745 and UK MDR 2002. Assist with notified body, customer, and attend supplier audits. Monitor regulatory changes and assist to align internal processes and documentation accordingly.
- Documentation and Reporting: Assist with creation, maintenance, and review of quality-related documentation (Procedures, protocols, and validation reports). Maintain accurate records of quality checks, audits and CAPA.
- Cross-Functional Collaboration: Work closely with departments such as Engineering, Design, Sales team, and Customer service to ensure the Quality and compliance are embedded throughout the organisation. Collaborate with stakeholders to resolve quality issues.
Education: Bachelor’s degree in quality assurance, Life Sciences, or a related field. Or alternatively a minimum 4 years’ experience in a QA/RA role in Medical Device Manufacturing or Pharmaceuticals.
Experience: Familiarity with industry-specific standards and regulations ISO 13485:2016, EU Medical Device Regulations (MDR) 2017/745 and UK MDR 2002. Experience in assisting with notified body audits.
Skills: Excellent organisational and communication skills. Proficiency in Microsoft Office Suite. ISO 13485:2016 Internal or Lead Auditor qualified preferable.
Work Environment: The position will be office based and will involve working closely with cross-functional teams.
Quality and Regulatory Assistant employer: MediTECH (B.N.O.S. Meditech Ltd.)
Contact Detail:
MediTECH (B.N.O.S. Meditech Ltd.) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Assistant
✨Tip Number 1
Familiarise yourself with ISO 13485:2016 and the EU Medical Device Regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device industry.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who have experience in quality assurance roles. Attend relevant industry events or webinars to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality management systems in previous roles. Highlight any experience you have with internal audits or regulatory compliance to showcase your practical knowledge.
✨Tip Number 4
Research Meditech and their recent developments, especially regarding their medical oxygen products. Being knowledgeable about the company’s current projects and challenges will help you stand out during the interview process.
We think you need these skills to ace Quality and Regulatory Assistant
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the responsibilities and requirements of the Quality and Regulatory Assistant position. Highlight key skills and experiences that align with the role.
Tailor Your CV: Customise your CV to reflect relevant experience in quality assurance and regulatory compliance, particularly focusing on ISO 13485:2016 and EU Medical Device Regulations. Use specific examples to demonstrate your expertise.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance in the medical device industry. Mention your understanding of the company's mission and how your background makes you a perfect fit for the team.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial in quality assurance roles.
How to prepare for a job interview at MediTECH (B.N.O.S. Meditech Ltd.)
✨Know Your Regulations
Familiarise yourself with ISO 13485:2016 and the EU Medical Device Regulations (MDR) 2017/745. Be prepared to discuss how these regulations impact quality assurance processes and share any relevant experiences you have in compliance.
✨Showcase Your Organisational Skills
As a Quality and Regulatory Assistant, you'll need excellent organisational skills. Prepare examples of how you've managed documentation or conducted audits in the past, highlighting your attention to detail and ability to follow processes.
✨Demonstrate Cross-Functional Collaboration
This role requires working closely with various departments. Think of instances where you've successfully collaborated with other teams to resolve quality issues or improve processes, and be ready to share those stories.
✨Prepare Questions for Them
Interviews are a two-way street. Prepare insightful questions about the company's quality management system and how they handle regulatory changes. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
