At a Glance
- Tasks: Guide regulatory compliance and support projects in a fast-paced medical device environment.
- Company: Phagenesis, dedicated to transforming lives through innovative healthcare solutions.
- Benefits: Competitive salary, dynamic work culture, and opportunities for professional growth.
- Other info: Fast-paced environment with a focus on innovation and accountability.
- Why this job: Join a mission-driven team making a real impact in patient care.
- Qualifications: Experience in regulatory affairs within medical devices and strong analytical skills.
The predicted salary is between 40000 - 50000 € per year.
At Phagenesis, we are committed to transforming lives by eliminating the burden of neurogenic dysphagia. As we transform into a high-performing global organization, we’re looking for exceptional individuals who thrive in fast-paced, evolving environments, and bring a strong sense of ownership and urgency to their work. Our vision is clear—make Phagenyx the standard of care in ICU and acute care settings—and we need ambitious, mission-aligned talent to help us get there. We put patients first, operate with courage and trust, and foster a culture that values innovation, accountability, and a challenger mindset.
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
Qualifications
- 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 honors or equivalent qualification in a science or engineering discipline
- 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 Manchester, England, United Kingdom employer: Phagenesis Limited
At Phagenesis, we pride ourselves on being an exceptional employer that prioritises innovation and accountability in the healthcare sector. Our Manchester location offers a dynamic work environment where employees are encouraged to take ownership of their roles and contribute to meaningful projects that directly impact patient care. With a strong focus on professional development and a culture that values collaboration and trust, we provide our team members with the tools and opportunities they need to thrive in their careers.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist Manchester, England, United Kingdom
✨Tip Number 1
Network like a pro! Reach out to people in the regulatory affairs field, especially those at Phagenesis or similar companies. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU, UK, and US regulations. Be ready to discuss how your experience aligns with the role's responsibilities, especially around compliance and documentation.
✨Tip Number 3
Showcase your organisational skills! Bring examples of how you've managed regulatory documents or projects in the past. This will demonstrate your attention to detail and ability to handle the fast-paced environment at Phagenesis.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in being part of our mission to transform lives.
We think you need these skills to ace Regulatory Affairs Specialist Manchester, England, United Kingdom
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 skills align with our mission at Phagenesis!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about transforming lives through medical devices. Share specific examples of how you've demonstrated ownership and urgency in your previous roles—this will resonate with us.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. When filling out your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure their submissions are polished and professional.
Apply Through Our Website:We encourage you to apply directly through our website. This not only streamlines the process but also shows us that you're genuinely interested in joining our team at Phagenesis. Plus, it's super easy!
How to prepare for a job interview at Phagenesis Limited
✨Know Your Regulations
Make sure you brush up on EU, UK, and US regulations that affect Class II medical devices. Being able to discuss these confidently will show your understanding of the role and its requirements.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully navigated regulatory processes or contributed to compliance projects. This will demonstrate your hands-on experience and problem-solving skills.
✨Highlight Your Organisational Skills
Since this role requires excellent organisational skills, be ready to discuss how you manage documentation and data effectively. Share any tools or methods you use to stay organised in a fast-paced environment.
✨Emphasise Teamwork and Communication
Phagenesis values collaboration, so be prepared to talk about how you work within a team. Discuss any experiences where you liaised with different departments or external partners to achieve regulatory goals.
