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- Tasks: Manage regulatory compliance and technical documentation for medical devices.
- Company: Family-owned global leader in respiratory and medical devices.
- Benefits: Competitive salary, hybrid working model, and career growth opportunities.
- Why this job: Influence global operations and work on impactful projects in healthcare.
- Qualifications: 5-10 years in QARA with strong knowledge of MDD, MDR, and ISO standards.
- Other info: Collaborative environment with exposure to cutting-edge innovations.
The predicted salary is between 47000 - 63000 £ per year.
Location: Hybrid, Lancashire, UK
Salary: £55,000-£70,000
Company Overview: We are a family-owned global leader in respiratory and medical devices, covering over 27 locations worldwide. Renowned for innovation and quality, we are committed to delivering safe, effective, and life-changing solutions to patients around the globe.
Role Overview: We are seeking a highly skilled RA Manager to join our team as a stand-alone contributor. This is a hybrid role based in Lancashire, UK, with the opportunity to influence global operations. You will play a pivotal role in ensuring compliance, maintaining technical documentation, and supporting the transition from MDD to MDR, while managing risk and testing activities across our international markets.
Key Responsibilities:
- Own and maintain Technical Files and Design Dossiers in line with MDD/MDR and ISO 13485 requirements.
- Manage risk management activities, including preparation, review, and approval of risk assessments, mitigation strategies, and post-market surveillance inputs.
- Lead regulatory compliance activities, ensuring adherence to CE marking requirements and supporting global regulatory submissions.
- Conduct internal audits, gap analyses, and compliance checks to identify and resolve potential quality or regulatory issues.
- Collaborate with cross-functional teams to review product testing data, validation reports, and CAPAs.
- Provide expert guidance on regulatory changes and ensure alignment with evolving global standards.
Requirements:
- Minimum of 5–10 years’ experience in QARA, ideally within the medical device sector.
- Strong knowledge of MDD, MDR, ISO 13485, and risk management (ISO 14971).
- Experience in authoring and reviewing technical files, CAPAs, NCRs, and design history documentation.
- Understanding of global regulatory landscapes and experience working across multiple markets.
- Excellent communication and organizational skills with the ability to work independently.
- Lead Auditor certification preferred.
What We Offer:
- Opportunity to work on impactful global projects in a family-owned company that values its employees.
- Hybrid working model based in Lancashire, UK.
- Exposure to cutting-edge respiratory and medical device innovations.
- Collaborative, inclusive, and professional environment with scope for career growth.
How to Apply:
If you are a self-motivated QARA professional looking to take ownership of global compliance and technical documentation, please apply.
Regulatory Affairs Manager employer: Maclivaro Limited
Contact Detail:
Maclivaro Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend local meetups. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory challenges and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your pitch! Be clear about your skills and experiences, especially those related to MDD, MDR, and ISO standards. A confident and concise introduction can set the tone for a great conversation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of our family-owned company.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with MDD, MDR, and ISO 13485, as well as any relevant projects you've worked on. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs in the medical device sector. Share specific examples of how you've managed compliance and risk management in previous roles. We love a good story!
Showcase Your Communication Skills: As a Regulatory Affairs Manager, communication is key. In your application, demonstrate your ability to convey complex information clearly. Whether it's through your CV or cover letter, make sure we can see your knack for effective communication!
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 us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Maclivaro Limited
✨Know Your Regulations
Make sure you brush up on the MDD, MDR, and ISO 13485 standards before your interview. Being able to discuss these regulations confidently will show that you’re not just familiar with them but can also apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed risk assessments or led regulatory compliance activities. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Ask Insightful Questions
Come prepared with questions that demonstrate your interest in the company and the role. Inquire about their approach to transitioning from MDD to MDR or how they handle post-market surveillance. This shows you’re thinking critically about the position.
✨Emphasise Collaboration Skills
Since the role involves working with cross-functional teams, be ready to discuss how you’ve effectively collaborated with others in the past. Highlight any experiences where you’ve resolved conflicts or facilitated communication between departments.