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- Tasks: Lead quality assurance and regulatory affairs for a medical device start-up.
- Company: Join a dynamic London-based start-up focused on innovative medical devices.
- Benefits: Competitive salary, opportunity to shape the future of healthcare.
- Why this job: Be part of a growing team making a real impact in the medical field.
- Qualifications: Experience in QARA and familiarity with global medical device regulations required.
- Other info: Interviews start in January; connect on LinkedIn for updates.
The predicted salary is between 60000 - 65000 £ per year.
Job Title: Quality Assurance and Regulatory Affairs Lead
Salary: £60,000 – £65,000
Location: London, UK
Job Type: Permanent
A London based Start-up Medical Device company developing a Class 1 Measuring Device is on the look out for a Quality and Regulatory Lead to join their growing business. They are looking for an individual that is hard working and self motivated to assist with all things QARA.
Key Responsibilities:
- Developing and executing regulatory strategies for FDA clearance, followed by other markets.
- Installing and marinating an appropriate QMS (including risk management processes). This is likely to be compliant with ISO 13485 and CFR21 Part 820.
- Oversee internal audits and manage external inspections by notified bodies and regulatory authorities.
- Manage regulatory documentation, including submission dossiers, technical files, and risk management files (ISO 14971).
- Provide guidance on Verification and Validation activities, ensuring alignment with FDA and international standards (e.g., ISO 60601, ISO 10993).
- Ensure product labeling, packaging, and instructions for use (IFU) meet regulatory requirements for the US and other markets.
Experiences and Qualifications Required:
- Proven experience in QARA including preparing and submitting regulatory submissions and installing and managing a QMS.
- Familiarity with global medical device regulations, including CFR 21, EU MDR and UKCA, and associated market requirements.
- Experience with common international standards for electronic medical devices (ISO 13485, 14971, 10933, 60601).
- Experience with external audit of quality and risk management systems.
Interviews: Starting in January
How to apply: Apply to to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.
Quality Assurance and Regulatory Affairs Lead employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance and Regulatory Affairs Lead
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks mentioned in the job description, such as ISO 13485 and CFR 21. This knowledge will not only help you during the interview but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in Quality Assurance and Regulatory Affairs. Engaging with them on platforms like LinkedIn can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed regulatory submissions or implemented a Quality Management System. Real-life scenarios will showcase your expertise and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and changes in medical device regulations. Being knowledgeable about current events in the industry will show your passion and dedication, making you a more attractive candidate.
We think you need these skills to ace Quality Assurance and Regulatory Affairs Lead
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Assurance and Regulatory Affairs Lead position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your proven experience in QARA, particularly in preparing regulatory submissions and managing a Quality Management System (QMS). Use specific examples to demonstrate your familiarity with ISO standards and global medical device regulations.
Showcase Your Skills: Clearly outline your skills related to risk management processes, internal audits, and external inspections. Mention any relevant certifications or training that align with the requirements of the role.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your motivation for joining a start-up medical device company. Highlight your self-motivation and hard-working nature, as these traits are essential for the role.
How to prepare for a job interview at X4 Life Sciences
✨Know Your Regulations
Make sure you are well-versed in the relevant regulations such as CFR 21, EU MDR, and UKCA. Being able to discuss these confidently will show your expertise and readiness for the role.
✨Demonstrate QMS Experience
Prepare examples of how you've installed and managed a Quality Management System (QMS) in previous roles. Highlight specific challenges you faced and how you overcame them.
✨Showcase Your Audit Skills
Be ready to talk about your experience with internal audits and managing external inspections. Discuss any specific audits you've led or participated in and what the outcomes were.
✨Align with Company Values
Research the company’s mission and values. During the interview, express how your personal work ethic aligns with their goals, especially in terms of quality assurance and regulatory affairs.
