At a Glance
- Tasks: Lead Quality Assurance and Regulatory Affairs for innovative medical devices.
- Company: Rapidly growing medical device company focused on improving patient outcomes.
- Benefits: Career progression, hands-on experience, and a chance to shape quality strategies.
- Other info: Collaborative environment with opportunities to work on multiple projects.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Experience in Quality Assurance and Regulatory Affairs within the medical device industry.
The predicted salary is between 60000 - 80000 £ per year.
We are an ambitious and rapidly growing medical device company developing innovative products that improve patient outcomes and support healthcare professionals worldwide. As we continue to expand our product portfolio and international market presence, we are seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead our Quality and Regulatory function and play a critical role in bringing new medical devices to market.
This is an exciting opportunity for someone who thrives in a hands-on SME environment and enjoys building systems, processes, and documentation from the ground up while working closely with engineering, manufacturing, and leadership teams. Reporting directly to senior leadership, you will take ownership of Quality Assurance and Regulatory Affairs activities across a growing portfolio of medical devices.
You will be responsible for:
- Developing and maintaining technical documentation
- Supporting product development activities
- Ensuring regulatory compliance
- Driving quality throughout the entire product lifecycle
We are specifically looking for someone who has experience managing multiple medical device products and projects simultaneously, rather than supporting a single product line. This role requires a highly collaborative individual who can work effectively with R&D, engineering, manufacturing, suppliers, and external regulatory bodies while helping shape the future quality and regulatory strategy of the business.
Regulatory Affairs
- Support regulatory strategy for new and existing medical devices
- Coordinate regulatory submissions and product registrations in European and international markets
- Interface with Notified Bodies, Competent Authorities, and external regulatory consultants
- Review product changes and assess regulatory impact
- Maintain regulatory compliance throughout the product lifecycle
Quality Assurance
- Maintain and continuously improve the Quality Management System in accordance with ISO 13485
- Ensure quality requirements are integrated throughout product design, development, manufacturing, and post-market activities
- Support supplier qualification and supplier quality activities
- Ensure effective document control systems are maintained
- Provide quality and regulatory guidance to cross-functional teams
- Support implementation of scalable quality processes suitable for a growing business
- Act as the Quality and Regulatory representative within New Product Development projects
Risk Management Files
- Work closely with engineering and production teams to ensure products are designed for manufacturability and regulatory compliance
- Regulatory submissions
- Quality procedures and work instructions
Qualifications
- Degree in Engineering, Life Sciences, Medical Devices, Quality, Regulatory Affairs, or a related discipline
- Significant experience in Quality Assurance and Regulatory Affairs within the medical device industry
- Experience supporting New Product Development and design transfer projects
- Strong technical documentation writing skills
- Experience managing multiple products and regulatory projects simultaneously
- Experience working within an SME, start-up, or rapidly growing medical device company
- Excellent stakeholder management and communication skills
- Experience with Class II or Class III medical devices
- Experience implementing or improving quality systems within a growing organisation
- Experience scaling regulatory and quality processes to support portfolio growth
Opportunity to shape the Quality and Regulatory function of a growing medical device business. Genuine opportunity for career progression as the company continues to grow. If you are an experienced QARA professional looking for an opportunity to build, influence, and drive quality and regulatory excellence within a growing medical device company, we would love to hear from you.
Quality and Regulatory Affairs Manager in Hertford employer: Maclivaro Limited
As a rapidly growing medical device company, we offer an exciting and dynamic work environment where innovation thrives. Our collaborative culture encourages hands-on involvement in shaping quality and regulatory strategies, providing ample opportunities for professional growth and career progression. With a commitment to improving patient outcomes and supporting healthcare professionals, we empower our employees to make a meaningful impact in the medical field.
StudySmarter Expert Advice🤫
We think this is how you could land Quality and Regulatory Affairs Manager in Hertford
✨Network Like a Pro
Get out there and connect with people in the medical device industry! Attend conferences, webinars, or local meetups. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your experience with quality assurance and regulatory affairs. Share specific examples of how you've managed multiple projects and improved processes in previous roles.
✨Tailor Your Approach
Every company is different, so do your homework! Understand their products and challenges, and be ready to discuss how your skills can help them achieve their goals. This shows you're genuinely interested and not just sending out generic applications.
✨Apply Through Our Website
Don't forget to check out our website for the latest job openings! Applying directly through us not only makes it easier for you but also helps us keep track of your application. Plus, we love seeing familiar faces!
We think you need these skills to ace Quality and Regulatory Affairs Manager in Hertford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality and Regulatory Affairs role. Highlight your experience with medical devices, quality management systems, and regulatory compliance. We want to see how your background aligns 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 in the medical device industry. Share specific examples of your achievements and how they relate to the role at StudySmarter.
Showcase Your Technical Writing Skills:Since strong technical documentation writing skills are key for this role, include examples of your previous work or projects where you developed technical documents. This will help us see your ability to communicate complex information clearly.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us. We can’t wait to hear from you!
How to prepare for a job interview at Maclivaro Limited
✨Know Your Stuff
Make sure you brush up on the latest regulations and standards in the medical device industry, especially ISO 13485. Be ready to discuss how you've implemented quality systems in your previous roles and how they can be applied to this position.
✨Showcase Your Experience
Prepare specific examples of how you've managed multiple medical device projects simultaneously. Highlight your experience with regulatory submissions and interactions with Notified Bodies, as this will demonstrate your capability to handle the responsibilities of the role.
✨Be Collaborative
This role requires a highly collaborative approach, so be prepared to discuss how you've worked effectively with cross-functional teams in the past. Share examples of how you've communicated with R&D, engineering, and manufacturing to ensure compliance and quality throughout the product lifecycle.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company’s future. Inquire about their plans for expanding their product portfolio or how they envision the Quality and Regulatory function evolving as they grow.
