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- Tasks: Guide regulatory compliance and support projects for medical devices.
- Company: Dynamic medical device company focused on innovation and compliance.
- Benefits: Competitive salary, career development, and a collaborative work environment.
- Other info: Join a team that values detail-oriented individuals and offers growth opportunities.
- Why this job: Make a difference in healthcare by ensuring safety and compliance of medical devices.
- Qualifications: Degree in science or engineering; familiarity with regulatory processes.
The predicted salary is between 40000 - 50000 £ per year.
Role Overview: 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 ISO13485 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
Desirable Experience:
- 3-5 years experience of working within a regulatory department in a medical device company
Skills & Capabilities:
- Excellent organizational skills and attention to detail
- Excellent analytical thinking and ability to process and organize data effectively
- A quick learner and self-motivated worker
- Good teamworking capabilities
- IT literate and capable (Excel, Word and database tools)
Regulatory Affairs Specialist in Manchester employer: Phagenesis
Contact Detail:
Phagenesis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist in Manchester
✨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
Showcase your organisational skills! During interviews, share examples of how you've managed complex regulatory projects or documentation. We want to see how you handle the nitty-gritty details that are crucial in this role.
✨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 Regulatory Affairs Specialist in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with EU, UK, and US regulations, and any relevant projects you've worked on. We want to see how your background aligns with our needs!
Showcase Your Skills: Don’t forget to showcase your excellent organisational skills and attention to detail. Use specific examples from your past roles to demonstrate how you’ve successfully managed regulatory documentation or compliance tasks. This will help us see your capabilities in action!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Explain why you're passionate about regulatory affairs and how your experience makes you a great fit for our team. We love seeing enthusiasm and a personal touch, so let your personality come through!
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 keen on joining StudySmarter!
How to prepare for a job interview at Phagenesis
✨Know Your Regulations
Make sure you brush up on EU, UK, and US regulations related to Class II medical devices. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics but are genuinely invested in the field.
✨Showcase Your Experience
Prepare to talk about your previous experience in regulatory affairs, especially any projects where you prepared FDA submissions or updated Technical Files. Use specific examples to illustrate your skills and how they align with the responsibilities of the role.
✨Demonstrate Organisational Skills
Since this role requires excellent organisational skills, be ready to discuss how you manage documentation and data. You might want to share a story about a time you successfully organised a complex project or maintained a regulatory database.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company’s regulatory processes or their approach to post-market surveillance. This shows that you’re not only interested in the role but also in how you can contribute to the team’s success.