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- Tasks: Lead quality and regulatory strategy for medical devices, ensuring compliance and high standards.
- Company: Dynamic medical equipment manufacturer with a focus on innovation and quality.
- Benefits: Competitive salary, career development, and a supportive team environment.
- Why this job: Make a real impact in the medical field while leading a passionate team.
- Qualifications: Experience in QARA within medical devices and strong leadership skills.
- Other info: Office-based role in Middlesex with excellent growth opportunities.
The predicted salary is between 48000 - 72000 £ per year.
Location: Middlesex, West London, Surrey
Please note:
- You MUST be able to work in the office 5 days per week through your probationary period
- You MUST have medical devices sector experience in the UK
- You MUST have the right to work in the UK without restriction
Purpose of the Role
To lead UK quality and regulatory strategy, ensuring compliance across the company's product portfolio. This role is pivotal in enabling market access, maintaining high standards, and embedding quality throughout the product lifecycle.
Strategic Leadership
- Represent role model or servant leader model leadership as a member of senior site management team.
- Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.
- Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.
- Represent the company in regulatory compliance audits and external engagements.
Regulatory Affairs
- Oversee global product registrations and submissions, including CE marking and international approvals for company products.
- Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification.
- Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.
Quality Assurance
- Maintain and enhance the Quality Management System (QMS).
- Lead internal and supplier audits, investigations, and corrective actions.
- Analyse QA data to drive continuous improvement and risk mitigation.
Project Oversight
- Lead QARA team in managing regulatory documentation and audit readiness.
- Support change control and post-market surveillance activities.
Team Development
- Mentor and develop QARA team members.
- Ensure training programmes reflect current regulatory and quality practices.
Skills & Experience
- Proven leadership in QARA within medical devices or regulated industries.
- Experience with CE marking, Medical Device Requirements, both EU and UK, regulatory submissions, electrical safety requirements, software validation, and international compliance.
- Excellent communication and stakeholder engagement skills.
- Familiarity with electronic QMS and project management tools.
Desirable Qualifications
- Degree in Engineering, Life Sciences, or related field (Master's preferred).
- Experience working directly with regulatory bodies.
- Lead Auditor Certification.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance and Management
Industries: Medical Equipment Manufacturing and Manufacturing
Quality and Regulatory Affairs Manager employer: Nicholas Associates
Contact Detail:
Nicholas Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend local meetups. You never know who might have the inside scoop on job openings in Quality and Regulatory Affairs.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and regulatory requirements. We recommend practising common interview questions related to quality assurance and compliance to show you're the right fit.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've led teams or projects in the past, especially in the medical devices sector. We want to see how you can drive quality and compliance in our organisation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace Quality and Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality and Regulatory Affairs role. Highlight your experience in the medical devices sector and any relevant regulatory compliance achievements. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and regulatory affairs. Share specific examples of how you've led teams or managed compliance in previous roles, so we can see your leadership style.
Showcase Your Skills: Don’t forget to highlight your technical skills, especially those related to ISO 13485 and CE marking. We’re looking for someone who knows their stuff, so make sure we can easily spot your expertise in these areas!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Nicholas Associates
✨Know Your Regulations
Make sure you brush up on the key regulations like ISO 13485 and MDR. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply them effectively in your role.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams or projects in the past, especially in the medical devices sector. Highlight your experience in mentoring and developing team members, as this is crucial for the role.
✨Understand the Company’s Products
Do your homework on the company’s product portfolio. Knowing their products inside out will help you discuss how you can ensure compliance and quality throughout the product lifecycle.
✨Prepare for Scenario Questions
Think about potential challenges you might face in the role and how you would address them. Be ready to discuss specific situations where you’ve successfully navigated regulatory hurdles or improved quality management systems.
