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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 the medical device consultancy sector.
- Benefits: Enjoy remote work flexibility and a competitive salary up to £65,000.
- Why this job: Be part of an innovative team shaping the future of medical technology.
- Qualifications: 3+ years in regulatory affairs with experience in medical devices required.
- Other info: This is a permanent role with opportunities for professional growth.
The predicted salary is between 39000 - 65000 £ 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
Join relevant online forums and groups focused on regulatory affairs and medical devices. Engaging in discussions can help you gain insights and make connections that could lead to job opportunities.
✨Tip Number 3
Consider reaching out directly to hiring managers or recruiters at X4 Life Sciences via LinkedIn. A personalised message expressing your interest in the Regulatory Affairs Consultant position can set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest regulations and guidelines related to medical devices, particularly software and AI technologies. Demonstrating your knowledge during interviews can showcase your expertise and commitment to the field.
We think you need these skills to ace Regulatory Affairs Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly in the medical device sector. Emphasise your expertise in software (SaMD) and AI/ML technologies, as well as any specific projects you've worked on that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying and how your skills match the requirements of the role. Mention your experience with EU MDR, IVDR, UKCA, and FDA pathways, and provide examples of successful regulatory submissions you've managed.
Highlight Key Achievements: In both your CV and cover letter, include quantifiable achievements that demonstrate your impact in previous roles. For instance, mention any successful regulatory approvals you facilitated or improvements you made to submission processes.
Proofread Your Application: Before submitting your application, carefully proofread all documents to ensure there are no spelling or grammatical errors. 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, UKCA, and FDA pathways. 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 in real-world scenarios.
✨Cross-Functional Collaboration
Be ready to discuss how you've worked with different teams such as QA, R&D, and clinical teams. Highlighting your ability to collaborate effectively will be crucial, as this role requires working across various departments.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current projects or challenges in regulatory affairs. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
