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- Tasks: Ensure compliance with regulations for Class II medical devices and support FDA submissions.
- Company: Phagenesis, a leading medical device company based in Manchester.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Strong analytical skills needed in a fast-paced environment.
- Why this job: Join a dynamic team making a difference in healthcare through innovative medical devices.
- Qualifications: Bachelor's degree in science or engineering and 3-5 years of regulatory experience.
The predicted salary is between 40000 - 50000 £ per year.
Phagenesis in Manchester is looking for a Regulatory Officer responsible for ensuring compliance with EU, UK, and US regulations for Class II medical devices. The role involves:
- Preparing and updating Technical and Risk Management Files
- Supporting FDA submissions
- Maintaining Post-market Surveillance processes
The ideal candidate should have:
- A Bachelor's degree in science or engineering
- 3-5 years of experience in a regulatory role within a medical device company
- Strong analytical and organizational skills
Medical Device Regulatory Affairs Specialist (EU/UK/US) in Manchester employer: Phagenesis
Contact Detail:
Phagenesis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Regulatory Affairs Specialist (EU/UK/US) in Manchester
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn. Join relevant groups and engage in discussions to get your name out there and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on EU, UK, and US regulations. We recommend creating a cheat sheet of key compliance points and recent changes in the industry to impress your interviewers with your knowledge.
✨Tip Number 3
Showcase your analytical skills! During interviews, be ready to discuss specific examples of how you've tackled regulatory challenges in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Medical Device Regulatory Affairs Specialist (EU/UK/US) in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, especially with Class II medical devices. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can help us at Phagenesis. Be specific about your experience with EU, UK, and US regulations.
Showcase Your Analytical Skills: Since strong analytical skills are essential for this role, make sure to include examples of how you've used these skills in past positions. Whether it's preparing Technical Files or conducting risk assessments, we want to see your thought process!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us during the hiring process!
How to prepare for a job interview at Phagenesis
✨Know Your Regulations
Make sure you brush up on the specific EU, UK, and US regulations related to Class II medical devices. Familiarise yourself with the latest updates and how they impact compliance. This will show your potential employer that you're not just knowledgeable but also proactive about staying informed.
✨Prepare Your Technical Files
Since the role involves preparing and updating Technical and Risk Management Files, it’s a good idea to have examples ready. Think about how you've handled similar tasks in the past and be prepared to discuss your approach and any challenges you faced.
✨Showcase Your Analytical Skills
Highlight your analytical skills during the interview by discussing specific instances where you’ve used them to solve problems or improve processes. Be ready to explain how you approach data analysis and decision-making in a regulatory context.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company’s current projects or challenges in regulatory affairs. This not only shows your interest in the role but also gives you a chance to demonstrate your understanding of the industry and the specific demands of the position.