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- Tasks: Guide clients on regulatory submissions for medical devices, focusing on software and AI technologies.
- Company: Join X4 Life Sciences, a leader in regulatory consultancy for the medical device sector.
- Benefits: Enjoy remote work flexibility and a competitive salary of up to £65,000.
- Why this job: Make an impact in healthcare by shaping regulations for innovative medical technologies.
- Qualifications: 3+ years in regulatory affairs, with experience in medical devices and excellent communication skills.
- Other info: This is a permanent role with opportunities for professional growth and networking.
The predicted salary is between 46800 - 78000 £ per year.
If you are a seasoned Regulatory professional within the Medical Device space, this role might be for you! We’re looking for a Regulatory Consultant who can support a diverse portfolio of clients with particular expertise in medical device software (SaMD) and AI/ML technologies.
Key Responsibilities:
- Provide regulatory guidance on global submissions for medical devices, with a focus on software (SaMD) and AI-based technologies.
- Develop and implement regulatory strategies for EU MDR, IVDR, UKCA, and FDA pathways.
- Prepare and review regulatory submissions including 510(k), Technical Documentation, and Pre-Subs.
- Collaborate cross-functionally with QA, R&D, and clinical teams.
Experience and Qualifications Required:
- 3+ years of regulatory affairs experience in the medical device sector, ideally including consultancy work.
- Experience preparing and submitting 510(k), CE marking files, or UKCA documentation.
- Excellent communication and project management skills.
How to apply:
Apply to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.
Regulatory Affairs Consultant employer: JR United Kingdom
Contact Detail:
JR United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who specialise in medical devices. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends in regulatory requirements.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines related to SaMD and AI/ML technologies. This knowledge will not only boost your confidence but also demonstrate your commitment to staying updated in this rapidly evolving sector.
✨Tip Number 3
Consider reaching out to current or former employees of X4 Life Sciences on LinkedIn. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach during interviews.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios faced in regulatory affairs consultancy. Think about how you would handle specific challenges related to EU MDR, IVDR, and FDA submissions, as these are likely to come up.
We think you need these skills to ace Regulatory Affairs Consultant
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Consultant position. Tailor your application to highlight your relevant experience in medical devices, particularly in software and AI technologies.
Craft a Targeted CV: Your CV should reflect your 3+ years of regulatory affairs experience. Emphasise your expertise in preparing submissions like 510(k) and CE marking files. Use specific examples to demonstrate your project management skills and collaboration with cross-functional teams.
Write a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background aligns with the role. Mention your familiarity with EU MDR, IVDR, UKCA, and FDA pathways, and explain how you can contribute to the company's success.
Proofread and Edit: Before submitting your application, carefully proofread your documents. Check for any grammatical errors or typos, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at JR United Kingdom
✨Know Your Regulations
Familiarise yourself with the latest regulations surrounding medical devices, particularly EU MDR, IVDR, and UKCA. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience with regulatory submissions like 510(k) and CE marking files. This will demonstrate your hands-on knowledge and problem-solving skills.
✨Communicate Clearly
Since excellent communication is key in this role, practice articulating complex regulatory concepts in a clear and concise manner. This will help you stand out as a candidate who can effectively collaborate with cross-functional teams.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to regulatory affairs and their client portfolio. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
