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- Tasks: Lead a team ensuring quality and regulatory compliance in life sciences.
- Company: Join a reputable life sciences firm known for innovative products in diagnostics.
- Benefits: Enjoy potential hybrid work options and a competitive salary of around £65,000.
- Why this job: Make a real impact in a vital industry while developing your leadership skills.
- Qualifications: Experience in quality assurance and regulatory affairs is essential.
- Other info: This role offers a chance to work closely with the Managing Director.
The predicted salary is between 52000 - 78000 £ per year.
Location: Buckinghamshire
Sector: Life Sciences
Salary: circa £65,000
Our client is an established life sciences business based in Buckinghamshire. They distribute and manufacture high-quality and innovative products, including in-vitro diagnostics, laboratory reagents, and biological materials, across the European life sciences market. An opportunity has become available for an experienced Quality Assurance and Regulatory Affairs Manager to join the company on a permanent basis. Ideally, this will be an on-site position; however, some hybrid flexibility may be available depending on circumstances.
The Role: This is a key role within the Quality and Regulatory team, responsible for managing a small team across Production and Quality. Reporting to the Managing Director, the successful candidate will serve as the primary contact and person responsible for Quality and Regulatory Compliance across the business.
Key responsibilities include:
- Implementing quality and regulatory directives to ensure compliance
- Maintaining the company's Quality Management Systems (QMS) in line with ISO 9001, ISO 13485, and ISO 17025
- Ensuring regulatory compliance for in vitro diagnostics – IVDD/IVDR and CE marking
- Leading audits in accordance with ISO 13485, ISO 9001, and ISO 17025
- Handling non-conformities and deviations
- Managing a small Quality and Production team to ensure...
Quality Assurance & Regulatory Affairs Manager employer: Click To Hired
Contact Detail:
Click To Hired Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance & Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 9001, ISO 13485, and ISO 17025. Being able to discuss these in detail during your interview will demonstrate your expertise and commitment to quality assurance.
✨Tip Number 2
Network with professionals in the life sciences sector, particularly those involved in quality assurance and regulatory affairs. Attend industry events or join relevant online forums to connect with potential colleagues and gain insights into the company culture.
✨Tip Number 3
Prepare to showcase your leadership skills, as this role involves managing a small team. Think of examples from your past experiences where you successfully led a team or project, and be ready to discuss these during your interview.
✨Tip Number 4
Research the company’s products and their impact on the life sciences market. Understanding their offerings will allow you to tailor your conversation and show genuine interest in how you can contribute to their success.
We think you need these skills to ace Quality Assurance & Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance and regulatory affairs. Emphasise your familiarity with ISO standards and any previous roles where you managed compliance or led audits.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your background aligns with their needs, particularly in managing teams and ensuring regulatory compliance.
Showcase Relevant Achievements: In your application, include specific examples of past achievements related to quality management systems and regulatory compliance. Quantify your successes where possible, such as improvements in audit results or successful implementation of QMS.
Proofread Your Application: Before submitting, carefully proofread your application 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 Click To Hired
✨Know Your Standards
Familiarise yourself with ISO 9001, ISO 13485, and ISO 17025. Be prepared to discuss how you have implemented these standards in previous roles and how they relate to the company's Quality Management Systems.
✨Showcase Your Leadership Skills
As this role involves managing a small team, be ready to share examples of your leadership experience. Discuss how you've motivated teams, handled conflicts, and ensured compliance within your team.
✨Prepare for Regulatory Questions
Expect questions about regulatory compliance, particularly regarding in vitro diagnostics and CE marking. Brush up on relevant regulations and be ready to explain how you've navigated these in past positions.
✨Demonstrate Problem-Solving Abilities
Be prepared to discuss specific instances where you've handled non-conformities or deviations. Highlight your analytical skills and how you approach problem-solving in a quality assurance context.
