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- Tasks: Guide regulatory compliance and assist in key projects for medical devices.
- Company: Dynamic company focused on innovation in healthcare regulations.
- Benefits: Competitive salary, flexible hours, and opportunities for professional growth.
- Other info: Join a collaborative team dedicated to improving patient safety.
- Why this job: Make a difference in healthcare by ensuring compliance with vital regulations.
- Qualifications: Familiarity with ISO13485 and QMSR processes is essential.
The predicted salary is between 40000 - 50000 £ per year.
This role is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with EU, UK and US regulations.
Key Responsibilities:
- Preparation of updates to the Technical File
- Support FDA submissions
- Preparation of updates to the Risk Management File
- Maintaining and updating Medical Devices files and Design History Files
- Administration of Applied Standards processes
- Maintenance of Post-market Surveillance processes
- Organization of PMS meetings
- Maintenance of PMS Plans, PSUR, PMCF Plans/Reports
- Compiling documentation and data for internal and external customers including the Notified Body
- Check, organize and update Regulatory documentation
- Support maintenance of regulatory database registrations
- Liaison with economic operators and management of documentation repositories
Essential Experience:
A familiarity with operating to IS013485 and/or QMSR compliant processes.
Regulatory Affairs Specialist employer: Phagenesis
Contact Detail:
Phagenesis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU, UK, and US regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills in regulatory affairs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can help keep you top of mind for hiring managers.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with regulatory requirements and any relevant projects you've worked on. We want to see how your skills align with our needs!
Showcase Your Knowledge: In your cover letter, showcase your understanding of EU, UK, and US regulations. Mention any specific experiences you have with FDA submissions or maintaining Technical Files. This will help us see your expertise right from the start!
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate straightforward communication!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at Phagenesis
✨Know Your Regulations
Make sure you brush up on EU, UK, and US regulatory requirements related to medical devices. Being able to discuss specific regulations and how they apply to the role will show your expertise and preparedness.
✨Prepare for Technical Questions
Expect questions about the Technical File and Risk Management File. Familiarise yourself with the processes involved in preparing updates and submissions, as well as any relevant standards like ISO 13485. This will help you demonstrate your technical knowledge.
✨Showcase Your Project Management Skills
Since the role involves managing various regulatory projects, be ready to discuss your experience in project management. Highlight any tools or methodologies you've used to keep projects on track, especially in a regulatory context.
✨Engage with Real-World Examples
Prepare to share specific examples from your past work that illustrate your ability to maintain compliance and manage documentation effectively. This could include experiences with FDA submissions or post-market surveillance processes, which will resonate well with the interviewers.