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- Tasks: Prepare and review regulatory documents for medical devices and guide compliance strategies.
- Company: Join a leading firm in the medical device regulatory space.
- Benefits: Gain valuable experience in a dynamic environment with potential for future opportunities.
- Why this job: Make a real impact in healthcare by ensuring device safety and compliance.
- Qualifications: Experience in regulatory affairs and strong communication skills required.
- Other info: Collaborative team atmosphere with a focus on professional growth.
The predicted salary is between 36000 - 60000 £ per year.
G&L are searching for a Med Devices specialist for a 6 month contract for a role within our CMC Regulatory Affairs Devices team. This position will focus on providing regulatory expertise for medical devices and combination products. The position involves developing and reviewing Design History Files and Technical Files, guiding regulatory strategies, and ensuring compliance with the major territories of US FDA and EU EMA.
Key Responsibilities:
- Prepare and review Design History and Technical Files for combination and standalone devices.
- Plan and manage submissions to regulatory bodies and notified bodies.
- Provide regulatory guidance to CMC and technical teams.
- Support lifecycle management and change strategies for medical devices and combination products.
Skills and Qualifications:
- Experience in medical device or combination product regulatory affairs.
- Strong communication, teamwork, and problem-solving skills.
- Attention to detail and effective time management.
- Proficiency in Word, Excel, and document management systems.
- Degree in Engineering, Pharmacy, Chemistry, or related discipline.
Preferred Experience:
- Global regulatory experience with a specific focus on US/ EU requirements.
- Hands-on involvement with Design History and Technical Files.
- Understanding of lifecycle impacts on regulatory submissions.
- Understanding of the operation of Veeva Vault document management system
Regulatory Affairs Medical Devices employer: G&L Scientific
Contact Detail:
G&L Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Medical Devices
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with medical devices. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your next opportunity.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of US FDA and EU EMA regulations. Be ready to discuss how your experience aligns with the responsibilities of the role, especially around Design History Files and Technical Files. We want you to shine!
✨Tip Number 3
Don’t just apply anywhere—focus on companies that excite you! Tailor your applications to highlight your relevant experience in medical device regulatory affairs. And remember, applying through our website can give you an edge!
✨Tip Number 4
Stay organised! Keep track of your applications, follow-ups, and networking efforts. Use tools like spreadsheets or apps to manage your job search effectively. This will help you stay on top of deadlines and opportunities.
We think you need these skills to ace Regulatory Affairs Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in medical device regulatory affairs. We want to see how your skills align with the key responsibilities mentioned in the job description, so don’t hold back on showcasing your relevant expertise!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for our CMC Regulatory Affairs Devices team. Share specific examples of your past work with Design History Files and Technical Files to grab our attention.
Show Off Your Communication Skills: Since strong communication is key for this role, make sure your application reflects that. Keep your language clear and concise, and don’t forget to proofread for any typos or errors. We love attention to detail!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at G&L Scientific
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of US FDA and EU EMA regulations. Familiarise yourself with the specifics of Design History Files and Technical Files, as well as lifecycle management strategies. This will show that you're not just a candidate, but someone who understands the ins and outs of regulatory affairs.
✨Showcase Your Teamwork Skills
Since this role involves working closely with CMC and technical teams, be ready to discuss examples of how you've successfully collaborated in the past. Highlight your communication skills and problem-solving abilities, as these are crucial for navigating the complexities of medical device regulations.
✨Be Detail-Oriented
Attention to detail is key in regulatory affairs. Prepare to demonstrate how you've managed complex documents or submissions in previous roles. Bring examples of your work with document management systems like Veeva Vault, if applicable, to showcase your proficiency.
✨Prepare Questions About the Role
Think of insightful questions to ask during the interview. Inquire about the specific challenges the team faces with regulatory submissions or how they manage changes in product lifecycle. This shows your genuine interest in the position and helps you assess if it's the right fit for you.