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- Tasks: Lead quality and regulatory efforts in the medical devices sector, ensuring compliance and continuous improvement.
- Company: Join a rapidly growing SME in the innovative medical devices space.
- Benefits: Enjoy hybrid working options and be part of a dynamic management team.
- Why this job: Make a real impact in quality management while collaborating with passionate professionals.
- Qualifications: Degree in Science or Engineering; 2-3 years in Medical Devices; knowledge of UK & EU regulations.
- Other info: Immediate start available; opportunity to shape the future of medical device quality.
The predicted salary is between 48000 - 72000 £ per year.
QUALITY AND REGULATORY MANAGER – MEDICAL DEVICES
Permanent
ASAP Start
Epson area, Surrey. Hybrid working.
Ever wanted to be part of a management team but actually achieve something?
How about moving from big Corporate to a rapidly growing SME in the Medical Devices space.
Most importantly – are you passionate about quality & continuous improvement?
Then look no further!!!
You will need to be someone who balances the Quality duties (i.e. Quality re-writes and auditing) with Regulatory (documentation/process) duties for your company.
KEY ACCOUNTABILITIES:
- Ensuring the declaration of conformity and technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure
- Providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
- Ensuring personal and company compliance with local regulations, policies and procedures
- Product registration in the MHRA database to assure regulatory preconditions for continuous availability of our products on the market
- Liaise with counterparts in Headquarter on all registration application issues
- Active participation in company management meetings, internal processes and development
- Reporting Key metrics to the management team
- Forwarding requests made by the MHRA for samples to the manufacturer to ensure that the MHRA has samples or has been given access to the device
- Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
- Informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents relating to a device for which they have been designated
- Terminating legal relationship with the manufacturer if they act contrary to its obligations under these Regulations and inform the MHRA and the relevant notified body of that termination
- Responsibility for maintaining and improving the ISO 13485 certified Quality Management System.
- Participation in and conducting internal, 2nd and 3rd party audits.
- Training and onboarding administration
SKILLS/EXPERIENCE REQUIRED:
- The ideal candidate will be educated to degree level (or equivalent), preferably in a Science or Engineering discipline, and will bring previous experience of working within Regulatory Affairs in the Medical Device or IVD field.
- We are looking for candidates with a strong working knowledge of UK & EU MDR Directives, (90/385/EEC and/or 93/42/EEC and/or 98/79/EC), knowledge and understanding of the EU Medical Devices Regulations, (Regulation (EU) 2017/745 and 2017/746) and experience working within an ISO 13485 certified Quality System.
- Experience of working with regulatory frameworks outside the EU is desirable, but not essential.
- Good understanding of global regulatory requirements
- 2-3 years’ experience within the Medical Devices industry (on top of your other industry experience)
- Good working knowledge of Word and Excel
- Good command of spoken and written English
- Attention to detail
If you have not heard back from Projectus Consulting within 7 days please assume your application has been unsuccessful on this occasion only
Regulatory and Quality Manager - Medical Devices (ISO13485/MDR) employer: PROJECTUS
Contact Detail:
PROJECTUS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory and Quality Manager - Medical Devices (ISO13485/MDR)
✨Tip Number 1
Make sure to familiarize yourself with the specific ISO 13485 standards and the UK & EU MDR Directives. Understanding these regulations deeply will not only help you in interviews but also demonstrate your commitment to quality and compliance.
✨Tip Number 2
Network with professionals in the Medical Devices industry, especially those who have experience with regulatory affairs. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss real-life examples of how you've contributed to quality management systems or regulatory compliance in your previous roles. This will showcase your practical experience and problem-solving skills.
✨Tip Number 4
Stay updated on the latest changes in medical device regulations and quality standards. Being knowledgeable about current trends and challenges in the industry will set you apart as a candidate who is proactive and informed.
We think you need these skills to ace Regulatory and Quality Manager - Medical Devices (ISO13485/MDR)
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Regulatory and Quality Manager position. Tailor your application to highlight your relevant experience in quality management and regulatory affairs within the medical devices sector.
Highlight Relevant Experience: In your CV and cover letter, emphasize your previous experience with ISO 13485 and your knowledge of UK & EU MDR Directives. Provide specific examples of how you've contributed to quality improvement and compliance in past roles.
Showcase Your Passion: Express your passion for quality and continuous improvement in your application. Use concrete examples to demonstrate how you have implemented quality initiatives or improved processes in previous positions.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your documents are clear, concise, and free of typos, as attention to detail is crucial in this role.
How to prepare for a job interview at PROJECTUS
✨Show Your Passion for Quality
Make sure to express your enthusiasm for quality and continuous improvement during the interview. Share specific examples from your past experiences where you successfully implemented quality management practices or improved processes.
✨Demonstrate Regulatory Knowledge
Be prepared to discuss your understanding of UK & EU MDR Directives and ISO 13485. Highlight any relevant experience you have in regulatory affairs within the medical devices sector, and be ready to answer questions about compliance and documentation processes.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory and quality management situations. Think of examples where you had to liaise with regulatory bodies like the MHRA or handle compliance issues, and explain how you approached these challenges.
✨Highlight Your Team Collaboration Skills
Since the role involves active participation in management meetings and collaboration with various teams, emphasize your ability to work well in a team environment. Share instances where you contributed to team success or facilitated communication between departments.
