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- Tasks: Guide regulatory compliance and manage documentation for medical devices.
- Company: Leading medical device company focused on innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team with a commitment to excellence and career advancement.
- Why this job: Make a difference in healthcare by ensuring safety and compliance of medical devices.
- Qualifications: Bachelor’s degree in science or engineering and 3-5 years in regulatory roles.
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.
- Preparation of updates to the Risk Management File
- Maintaining and updating Medical Devices files and Design History Files
- 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
- A familiarity with operating to IS013485 and/or QMSR compliant processes & procedures within a medical device company
- A working knowledge of EU, UK and US regulations that affect Class II medical devices
- A Bachelor’s degree with honours or equivalent qualification in a science or engineering discipline
- 3-5 years experience of working within a regulatory department in a medical device company
- Excellent analytical thinking and ability to process and organize data effectively
- IT literate and capable (Excel, Word and database tools)
Regulatory Specialist and Senior Specialist in Manchester employer: Phagenesis
Contact Detail:
Phagenesis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist and Senior Specialist in Manchester
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory 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
Showcase your analytical skills! During interviews, be ready to share examples of how you've effectively processed and organised data in past roles. We love seeing candidates who can demonstrate their problem-solving abilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are eager to make an impact in the regulatory space.
We think you need these skills to ace Regulatory Specialist and Senior Specialist in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory compliance, especially with EU, UK, and US regulations. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects or tasks you've tackled.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs in the medical device sector. We love seeing candidates who can connect their personal motivations to our mission at StudySmarter.
Showcase Your Analytical Skills: Since this role requires excellent analytical thinking, make sure to include examples of how you've processed and organised data effectively in your previous roles. We’re keen to see how you approach problem-solving!
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’re considered for the role. Plus, it shows you’re proactive and keen to join our team!
How to prepare for a job interview at Phagenesis
✨Know Your Regulations
Make sure you brush up on the EU, UK, and US regulations that impact Class II medical devices. Being able to discuss specific regulations and how they apply to the role will show your expertise and readiness for the position.
✨Showcase Your Experience
Prepare examples from your past roles where you've successfully navigated regulatory requirements or managed documentation. Highlighting your 3-5 years of experience in a regulatory department will help demonstrate your capability and fit for the role.
✨Be Data Savvy
Since the role involves compiling and organising data, be ready to discuss your proficiency with tools like Excel and any database systems you've used. You might even want to bring along a sample of your work to showcase your analytical skills.
✨Familiarise with QMSR Processes
Understanding ISO 13485 and QMSR compliant processes is crucial. Be prepared to talk about how you've applied these standards in your previous roles, as this will show your alignment with the company's operational framework.