Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead quality and regulatory compliance in advanced wound care and infection prevention.
- Company: Join Medicareplus, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, performance bonuses, and professional development opportunities.
- Why this job: Make a real impact on patient care and support healthcare professionals.
- Qualifications: Degree in life sciences or engineering and 4 years in regulatory compliance.
- Other info: Collaborative culture with excellent career progression in a dynamic environment.
The predicted salary is between 36000 - 60000 £ per year.
At Medicareplus, we pride ourselves on being a leading force in advanced wound care and infection prevention. Our mission focuses on creating innovative products that enhance patient care and support healthcare professionals. Join us in our commitment to excellence and become part of a culture that values collaboration and innovation.
We are seeking a Quality and Regulatory Manager (QA/RA) who will report directly into the Chief Financial Officer. The
Quality and Regulatory Manager
Manager will be responsible for ensuring continued compliance of the Company\’s Quality Management System with the relevant Medical Device Directives, Medical Device Regulations, International Standards, and Customer Requirements and provide knowledge and support to the company to enable it to operate within all the applicable Regulatory Guidelines.
Hours of work: Monday to Friday, based at our London HQ in Alperton, 8.30am -5pm.
Qualifications and experience:
Qualification in life sciences or engineering (BSc, or BEng)
4 years of experience in a regulatory compliance role in the medical device industry
Specific experience in regulatory affairs and submissions in the UK, European Canadian and American markets is required
Experience in dermatology products is desirable
Qualification or experience as a microbiologist is desirable
Responsibilities
- The
Quality and Regulatory Manager
will act as the person responsible for regulatory compliance within the definition of the EUMDR 2017/745. - Lead and mentor the QA team: Manage, train, and develop the QA/RA team, including hiring, performance reviews, and fostering a collaborative, results-driven environment
- Allocate resources: efficiently manage the team\’s workload, budget, and resources to meet project timelines and quality goals
- Manage all aspects of Quality and Regulatory compliance
- Manage Preparation and Maintenance of Product Registrations and Regulatory Files
- Oversee the Department\’s Management and promotion of the Quality System
- Operate the Quality Management System in compliance with the current ISO 13485
- Prepare and present Quality Data to analyse quality trends and support investigations, remediation, report and agree improvement initiatives
- Ensure that the company\’s Quality Policy and set objectives are met; plan and implement monitoring, measurement, analysis, and improvement of quality performances of the organisation
- Oversee the maintenance of the Technical Files and Documentation
- Responsible for the Document Control process and the efficient control of all documentation required by regulatory agencies
- Plan and manage internal audit activities and continuous improvement and coordinating audit corrective actions
- Oversee the management of the CAPA process to ensure corrective actions are established and that root- cause elimination is completed for identified issues
- Supervise and oversee the management the complaint handling process and medical device reporting activities and post-market surveillance
- Oversee the management the Non-Conformance process
- Author and approve the Standard Operating Procedures and work instructions
- Providing the necessary training to ensure employees understand QMS
Benefits:
Competitive salary with a performance-related bonus
Comprehensive benefits package
Opportunities for professional development and progression within a leading organisation
If you think you are suitable for this role, please apply now for an opportunity to influence change and drive success within a company that is dedicated to improving lives.
Quality and Regulatory Manager employer: Medicareplus International Ltd
Contact Detail:
Medicareplus International Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Manager
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those who work in quality and regulatory roles. Attend industry events or webinars to make connections and learn more about what companies like Medicareplus are looking for.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of relevant regulations and standards. Be ready to discuss how your experience aligns with the responsibilities of the Quality and Regulatory Manager role. We want to see your passion for compliance and quality management!
✨Tip Number 3
Showcase your leadership skills! If you’ve managed teams before, be sure to highlight your experience in mentoring and developing others. Companies like Medicareplus value collaboration and results-driven environments, so let us know how you can contribute to that culture.
✨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 joining our team at Medicareplus and being part of our mission to enhance patient care.
We think you need these skills to ace Quality and Regulatory Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality and Regulatory Manager role. Highlight your relevant experience in regulatory compliance, especially in the medical device industry, and don’t forget to mention any specific qualifications or experiences that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality management and regulatory affairs. Share specific examples of how you've contributed to compliance and quality improvements in your previous roles.
Showcase Your Team Leadership Skills: Since this role involves leading and mentoring a QA team, be sure to highlight your leadership experience. Talk about how you've managed teams, allocated resources, and fostered a collaborative environment in your past positions.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Medicareplus International Ltd
✨Know Your Regulations
Make sure you brush up on the relevant Medical Device Directives and Regulations. Familiarise yourself with ISO 13485 and any specific guidelines related to the UK, European, Canadian, and American markets. This knowledge will show that you're serious about compliance and ready to hit the ground running.
✨Showcase Your Experience
Prepare to discuss your previous roles in regulatory compliance, especially in the medical device industry. Highlight any experience you have with dermatology products or microbiology, as these are desirable qualifications for the role. Use specific examples to illustrate how you've successfully managed compliance issues in the past.
✨Demonstrate Leadership Skills
As a Quality and Regulatory Manager, you'll be leading a team. Be ready to talk about your leadership style and how you've mentored or developed teams in previous positions. Share examples of how you've fostered collaboration and driven results within your team.
✨Prepare Questions
Think of insightful questions to ask during the interview. Inquire about the company's current challenges in quality management or how they measure success in their QA/RA processes. This shows your genuine interest in the role and helps you assess if the company culture aligns with your values.
