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- Tasks: Lead a team ensuring quality and regulatory compliance in life sciences.
- Company: Join a reputable life sciences company in Buckinghamshire, known for innovative products.
- Benefits: Enjoy a competitive salary of £65,000 and potential hybrid work options.
- Why this job: Be part of a pivotal role that impacts health and safety across Europe.
- Qualifications: Experience in Quality Management Systems and knowledge of ISO standards required.
- Other info: This is a permanent position with opportunities for professional growth.
The predicted salary is between 39000 - 78000 £ per year.
Quality Assurance and Regulatory Affairs Manager
Quality Assurance & Regulatory Affairs Manager
Location: Buckinghamshire
Sector: Life Sciences
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 project delivery aligns with company expectations
Suitable Applicants:
Given the responsibilities of this role, we are seeking a candidate with prior industry experience within the Life Science sector in a senior Quality and Regulatory position, demonstrating competencies in the following areas:
- Proven experience in the implementation and maintenance of Quality Management Systems
- In-depth knowledge of ISO 13485, ISO 9001, and ISO 17025
- Experience leading ISO-accredited audits
- Sound knowledge of IVDD and IVDR regulations and CE marking
- Strong communication skills and strategic thinking abilities
- Team management experience with a hands-on leadership approach
In return, our client offers the opportunity to join the company on a permanent basis in a pivotal role. The position offers a salary of circa £65,000 (dependent on experience), along with benefits.
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I\’m interested in this job
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Compulsory fields are in bold .
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Quality Assurance and Regulatory Affairs Manager employer: taylorollinson Ltd
Contact Detail:
taylorollinson Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance and Regulatory Affairs Manager
✨Tip Number 1
Network with professionals in the life sciences sector, especially those involved in quality assurance and regulatory affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific ISO standards mentioned in the job description, such as ISO 13485 and ISO 9001. Consider obtaining certifications or attending workshops that focus on these standards to demonstrate your commitment and expertise.
✨Tip Number 3
Prepare for potential interviews by reviewing common questions related to quality management systems and regulatory compliance. Be ready to discuss your previous experiences leading audits and managing teams, as these are key aspects of the role.
✨Tip Number 4
Showcase your strategic thinking abilities by preparing examples of how you've successfully implemented quality directives in past roles. Highlight any improvements you made to processes or compliance that had a measurable impact on the organisation.
We think you need these skills to ace Quality Assurance and Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Quality Assurance and Regulatory Affairs, particularly within the Life Sciences sector. Emphasise your knowledge of ISO standards and any relevant regulatory compliance experience.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Discuss your experience with Quality Management Systems and your leadership style, showcasing how you can contribute to the team.
Highlight Relevant Achievements: In your application, include specific examples of past achievements related to quality assurance and regulatory compliance. Mention any successful audits you've led or improvements you've implemented in QMS.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in this role.
How to prepare for a job interview at taylorollinson Ltd
✨Know Your Standards
Familiarise yourself with ISO 9001, ISO 13485, and ISO 17025. Be prepared to discuss how you've implemented these standards in previous roles, as this will demonstrate your expertise and understanding of quality management systems.
✨Showcase Your Leadership Skills
As a Quality Assurance and Regulatory Affairs Manager, you'll be managing a team. Prepare examples of how you've successfully led teams in the past, focusing on your hands-on approach and ability to drive project delivery.
✨Understand Regulatory Compliance
Brush up on IVDD and IVDR regulations and CE marking processes. Be ready to explain how you have ensured compliance in your previous positions, as this is crucial for the role.
✨Prepare for Scenario Questions
Expect questions about handling non-conformities and deviations. Think of specific instances where you've resolved issues effectively, as this will highlight your problem-solving skills and strategic thinking.
