At a Glance
- Tasks: Support regulatory activities for medical devices and ensure compliance across global markets.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, career development opportunities, and a dynamic work environment.
- Other info: Collaborative team culture with opportunities for professional growth.
- Why this job: Join a hands-on role impacting healthcare products and regulatory strategies.
- Qualifications: Experience in Regulatory Affairs within the medical device sector and knowledge of MDR and FDA.
The predicted salary is between 40000 - 50000 £ per year.
Cure Talent are delighted to be partnered with a growing medical device manufacturer with a broad and diverse product portfolio across areas including IV therapy, diabetes care, surgical, anaesthesia and consumer health. Following continued expansion, they are now looking to add another Regulatory Affairs Specialist to their Quality & Regulatory team.
As the new Regulatory Affairs Specialist, you will support the ongoing development, maintenance and execution of regulatory activities across the business. This is a hands-on role with exposure across the full product lifecycle, working closely with internal teams to ensure products remain compliant across multiple global markets while helping to define regulatory strategy.
To be successful as the new Regulatory Affairs Specialist, you will have proven experience operating within Regulatory Affairs in the medical device sector, with detailed exposure to:
- Technical documentation
- Global regulatory frameworks including MDR and FDA
- Supporting regulatory strategy across a range of products
Your responsibilities will include:
- Support and maintain the Quality Management System in line with ISO 13485 requirements
- Ensure ongoing compliance with applicable regulatory requirements and standards
- Support document control activities including procedures, labelling and product documentation
- Contribute to UDI implementation and product lifecycle activities
- Monitor regulatory changes and support implementation across the business
Key qualifications:
- Proven Regulatory Affairs experience within the medical device industry
- Experience supporting regulatory strategy and submissions activities
- Working knowledge of MDR and FDA regulatory frameworks
- Experience working with technical documentation and regulatory files
Regulatory Specialist and Senior Specialist in London employer: CURE TALENT LIMITED
Join a dynamic and innovative medical device manufacturer that prioritises employee growth and development within a collaborative work culture. With a commitment to quality and compliance, this company offers hands-on experience across the full product lifecycle, ensuring that you will be at the forefront of regulatory affairs in a rapidly expanding industry. Located in a thriving area, employees benefit from a supportive environment that encourages continuous learning and professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist and Senior Specialist in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device sector on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Regulatory Affairs Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDR and FDA regulations. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during those crucial conversations.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and interests in the medical device field. We suggest using our website to find roles that excite you and match your skills perfectly!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. We believe this small gesture shows your enthusiasm and professionalism, making a lasting impression on hiring managers.
We think you need these skills to ace Regulatory Specialist and Senior Specialist in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs role. Highlight your experience in the medical device sector, especially with MDR and FDA frameworks. We want to see how your skills align with what we're looking for!
Showcase Relevant Experience:In your cover letter, showcase your hands-on experience with regulatory activities and technical documentation. We love seeing specific examples of how you've contributed to compliance and regulatory strategy in previous roles.
Be Clear and Concise:When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate straightforward communication, especially when it comes to complex topics like regulatory affairs.
Apply Through Our Website:Don't forget to apply 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 our team!
How to prepare for a job interview at CURE TALENT LIMITED
✨Know Your Regulations
Make sure you brush up on the latest regulations like MDR and FDA. Being able to discuss these frameworks confidently will show that you’re not just familiar with them, but that you can apply this knowledge practically in your role.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve successfully navigated regulatory challenges or contributed to compliance efforts. This will help demonstrate your hands-on experience and how it aligns with the needs of the company.
✨Understand the Product Lifecycle
Familiarise yourself with the full product lifecycle in the medical device sector. Be ready to discuss how you’ve supported products from development through to market launch, as this is crucial for the role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s regulatory strategy and how they handle compliance across different markets. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
