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- Tasks: Join our team as a Quality and Regulatory Specialist, ensuring compliance for medical devices.
- Company: Be part of a global leader in the Medical Device sector with innovative products.
- Benefits: Enjoy flexible hybrid work, private healthcare, dental cover, and subsidized gym membership.
- Why this job: Contribute to impactful projects in a collaborative environment while growing your career.
- Qualifications: Degree in Biomedical, Life Sciences, or Regulatory Affairs; experience in QA/RA required.
- Other info: Work from home 3 days a week; commute to London only 2 days.
The predicted salary is between 36000 - 60000 £ per year.
We are supporting our client, a global player within the Medical Device sector as they expand their QA/RA team by hiring a new Quality and Regulatory Specialist to join during a continued phase of growth for the business.
This role offers a very flexible and hybrid working pattern, based in our clients head office in London. This can be suitable for candidates not only based in London/surrounding counties, but also those further afield who can commute into London 2 days per week. The 2 days you work in the office are completely flexible and up to you.
About the company you are joining:
- A global Medical Device business, who manufacture and supply a diverse range of medical device products (Class I, Class IIa and Class III) as well as non-medical device products into the UK retail and wholesale markets.
- Benefiting from a having a strong/core product portfolio established within the market – ranging from pain relief products to general safety products, and there are further plans to launch more new products into the market soon.
About the Quality and Regulatory Specialist role:
The Quality and Regulatory Specialist is responsible for supporting the maintenance of quality and regulatory compliance for medical device products and non-medical device products.
Some of the key responsibilities for the Quality and Regulatory Specialist will involve the following:
- Quality Management System (QMS) Maintenance – ensuring ISO 13485 compliance, reviewing internal procedures, documents and SOPS for approval by QA/RA Manager and supporting with both internal/external audits.
- Batch release – conducting batch reviews and managing batch release to ensure compliance with regulatory standards.
- Complaint Handling and Post-Market Surveillance – Manage all complaints to ensure timely resolution and continuous improvement. Collect and analyse data for post-market surveillance (PMS) and contribute to risk assessments.
- Technical File/Documentation Maintenance – Maintain product technical documentation for ongoing product lines as well as drafting technical documentation for new products, ensuring that all documents remain compliant with regulatory requirements.
- Client and Service Provider Inquiries – Respond to product-related queries from clients and service providers.
- Quality Records Management – Maintain accurate and organised records related to staff training, product conformity files (PCF), deviations, and the quality manual.
We are looking for candidates for the Quality and Regulatory Specialist role who can demonstrate the following:
- Degree qualified in a Scientific discipline – Biomedical, Life Sciences or Regulatory Affairs.
- Proven experience working within Quality Assurance or Regulatory Affairs within the Medical Device field.
- Strong knowledge and understanding of ISO 13485 standards and Medical Device Regulation (MDR).
- An adaptable personality with a can-do attitude and grasps new concepts quickly.
- Enjoy working collaboratively with people in other areas of the business.
- Familiarity with Post-Market Surveillance, Vigilance Reporting, Clinical Evaluation, Biological Evaluations, Complaint handling, and document control.
What is on offer?
- Basic salary – £50,000pa
- Annual bonus
- Private Healthcare & Dental Cover
- Subsidised gym membership (up to £1,800 per annum)
Keywords: Quality and Regulatory Specialist, Quality Specialist, Regulatory Specialist, QA/RA Specialist, Medical Devices
Radar Recruitment | Quality and Regulatory Specialist - Medical Devices employer: Radar Recruitment
Contact Detail:
Radar Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Radar Recruitment | Quality and Regulatory Specialist - Medical Devices
✨Tip Number 1
Familiarize yourself with ISO 13485 standards and the Medical Device Regulation (MDR). Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality and regulatory compliance in the medical device sector.
✨Tip Number 2
Network with professionals in the Quality Assurance and Regulatory Affairs fields. Attend industry events or join relevant online forums to connect with others who work in medical devices. This can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with complaint handling and post-market surveillance. Be ready to share specific examples of how you've managed complaints or contributed to risk assessments in previous roles, as this is a key responsibility for the position.
✨Tip Number 4
Showcase your adaptability and collaborative spirit during the interview process. Highlight instances where you've successfully worked with cross-functional teams or adapted to new challenges, as these traits are highly valued in the role.
We think you need these skills to ace Radar Recruitment | Quality and Regulatory Specialist - Medical Devices
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality and Regulatory Specialist position. Highlight key responsibilities and required qualifications that match your experience.
Tailor Your CV: Customize your CV to emphasize your experience in Quality Assurance or Regulatory Affairs within the Medical Device sector. Include specific examples of your work with ISO 13485 standards and any relevant projects.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the medical device industry and your understanding of quality and regulatory compliance. Mention how your background aligns with the company's goals and values.
Highlight Relevant Skills: In your application, make sure to highlight skills such as complaint handling, post-market surveillance, and technical documentation maintenance. Use keywords from the job description to ensure your application stands out.
How to prepare for a job interview at Radar Recruitment
✨Show Your Knowledge of ISO 13485
Make sure to brush up on your understanding of ISO 13485 standards. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise and relevance for the Quality and Regulatory Specialist position.
✨Highlight Your Experience with Medical Devices
Share specific examples from your past work in Quality Assurance or Regulatory Affairs within the medical device sector. Discuss any relevant projects or challenges you've faced, and how you successfully navigated them.
✨Demonstrate Your Problem-Solving Skills
Prepare to talk about how you've handled complaints and post-market surveillance in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses and showcase your ability to resolve issues effectively.
✨Emphasize Collaboration and Adaptability
Since the role involves working with various teams, be ready to discuss how you collaborate with others. Share examples that highlight your adaptability and can-do attitude, especially in fast-paced environments.
