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For Companies At a Glance
- Tasks: Lead product compliance and quality systems for a growing portfolio.
- Company: Dynamic company focused on quality and regulatory excellence.
- Benefits: Competitive salary, profit share, hybrid work, and generous holiday allowance.
- Why this job: Shape compliance processes and drive ISO certification in a thriving environment.
- Qualifications: Experience in Quality, Compliance, or Regulatory roles with strong documentation skills.
- Other info: Join a hands-on team and make a real impact in the healthcare sector.
The predicted salary is between 40000 - 52000 £ per year.
We are seeking a hands-on Quality & Compliance Manager to take ownership of product compliance, quality systems, and regulatory documentation across a growing product portfolio. This role is responsible for managing technical files, ensuring compliance with UK, EU, and US regulations, and maintaining effective quality and environmental management systems. This is a key role within the business, offering the opportunity to lead the compliance function and play a central part in preparing the organisation for ISO 13485 certification.
Responsibilities
- Product Compliance & Documentation
- Own and manage Product Technical Files across the full product range
- Ensure products meet UKCA, CE, MHRA, FDA, and applicable US labeling and regulatory requirements
- Create, review, and maintain Instructions for Use (IFUs) in line with regulatory standards
- Maintain accurate and up-to-date compliance documentation
- Quality & Environmental Management Systems
- Operate, maintain, and continuously improve the ISO 9001 Quality Management System
- Manage and support the ISO 14001 Environmental Management System
- Ensure quality processes remain effective, compliant, and audit-ready
- Testing & Standards
- Create and manage product testing schedules
- Ensure products meet internal specifications and external regulatory requirements
- Coordinate testing activities and manage records of results and approvals
- Regulatory & Certification Readiness
- Lead the scoping and preparation activities for ISO 13485 certification
- Identify gaps, implement improvements, and support readiness for external audits
- Monitor regulatory changes and assess impact on products and systems
Skills & Experience
- Essential
- Proven experience in a Quality, Compliance, or Regulatory role
- Strong working knowledge of UKCA and CE marking
- Experience working with ISO 9001 and ISO 14001 management systems
- Experience managing technical documentation and product compliance files
- Confident working with regulatory standards and audits
- Desirable
- Experience with MHRA and FDA regulations
- Experience preparing for or working towards ISO 13485
- Background in medical devices, healthcare products, or other regulated manufacturing environments
Personal Attributes
- Hands-on and detail-oriented approach
- Strong organisational and documentation skills
- Able to work independently and take full ownership of the compliance function
- Clear communicator with internal and external stakeholders
- Comfortable working in a growing, evolving business environment
Employment Details & Benefits
- Salary: £50,000 - £65,000 (dependent on experience)
- Bonus: Profit share scheme
- Holiday: 23 days annual leave plus 8 bank holidays
- Additional leave: Bonus birthday holiday
- Benefits: Optional private healthcare scheme
- Working pattern: Full-time, 8:00am - 4:30pm
- Location: Hybrid
Why Apply?
This is an opportunity to take ownership of compliance within a growing business, shape the next phase of quality and regulatory systems, and play a pivotal role in achieving future certification milestones.
Quality & Compliance Manager in Hessle employer: Identify Talent
Contact Detail:
Identify Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality & Compliance Manager in Hessle
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their compliance needs and be ready to discuss how your experience aligns with their goals. Show them you’re not just another candidate!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality and compliance. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Quality & Compliance Manager in Hessle
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in quality and compliance. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant achievements!
Showcase Your Knowledge: Demonstrate your understanding of UKCA, CE marking, and ISO standards in your application. We’re looking for someone who knows their stuff, so include specific examples of how you've worked with these regulations in the past.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and make sure your key points stand out. This will help us see your qualifications quickly!
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Identify Talent
✨Know Your Regulations
Make sure you brush up on UKCA, CE, MHRA, and FDA regulations before the interview. Being able to discuss these confidently will show that you understand the compliance landscape and are ready to take ownership of product compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've managed technical documentation or led quality management systems. This will help demonstrate your hands-on experience and how it aligns with the responsibilities of the Quality & Compliance Manager role.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle certain compliance challenges or regulatory changes. Think through potential scenarios in advance and be ready to explain your thought process and problem-solving skills.
✨Communicate Clearly
As a Quality & Compliance Manager, you'll need to communicate effectively with various stakeholders. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory topics, to showcase your communication skills.
