At a Glance
- 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.
- Other info: Collaborative team atmosphere with a focus on professional growth.
- 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.
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 in Birmingham employer: G&L Scientific
G&L is an exceptional employer, offering a dynamic work environment that fosters collaboration and innovation within the CMC Regulatory Affairs Devices team. Employees benefit from comprehensive professional development opportunities, a supportive culture that values teamwork, and the chance to make a meaningful impact in the medical devices sector. Located in a vibrant area, G&L provides a unique advantage with access to industry-leading resources and networking opportunities.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Medical Devices in Birmingham
✨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! Check out our website for openings that match your skills in regulatory affairs for medical devices. Tailor your approach to show why you’re the perfect fit for their team.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to remind them of your expertise and enthusiasm for the role.
We think you need these skills to ace Regulatory Affairs Medical Devices in Birmingham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in medical device regulatory affairs. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant projects and 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 in medical devices and how your background makes you a perfect fit for our team. Keep it engaging and personal!
Showcase Your Attention to Detail:Since this role involves preparing Design History and Technical Files, we need to see that you have a keen eye for detail. Mention specific examples where your attention to detail made a difference in your previous work.
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 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 medical device regulations, especially those related to the US FDA and EU EMA. Familiarise yourself with the specifics of Design History Files and Technical Files, as these will likely come up in conversation.
✨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 how you’ve solved problems as part of a team.
✨Demonstrate Attention to Detail
Prepare to discuss how you ensure accuracy in your work, especially when it comes to regulatory submissions. Bring examples of how your attention to detail has positively impacted your previous projects or roles.
✨Familiarity with Tools is Key
If you have experience with Veeva Vault or similar document management systems, make sure to mention it. Being proficient in Word and Excel is also crucial, so be prepared to talk about how you use these tools in your day-to-day tasks.
