At a Glance
- Tasks: Support regulatory activities and ensure compliance for medical devices across global markets.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Other info: Collaborative environment with exposure to the full product lifecycle.
- Why this job: Join a dynamic team and make a real impact in the MedTech industry.
- Qualifications: Experience in Regulatory Affairs within the medical device sector and knowledge of MDR/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, and supporting regulatory strategy across a range of products.
Key Responsibilities- Support and maintain the Quality Management System in line with ISO 13485 requirements
- Prepare, review and maintain technical documentation across MDD, MDR, IVDR, UKCA, FDA and procedure packs
- 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
- Coordinate and support internal and external audits
- Monitor regulatory changes and support implementation across the business
- Proven Regulatory Affairs experience within the medical device industry
- Experience supporting regulatory strategy and submissions activities
- Working knowledge of MDR and FDA regulatory frameworks
- Strong understanding of ISO 13485
- Experience working with technical documentation and regulatory files
- Strong organisational skills with attention to detail
- Ability to work cross‑functionally within a regulated environment
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.
Regulatory Affairs Specialist - MedTech (MDR/FDA) employer: Cure Talent
Join a dynamic and innovative medical device manufacturer in Greater London, where your expertise as a Regulatory Affairs Specialist will be valued and nurtured. With a strong commitment to employee development, a collaborative work culture, and a diverse product portfolio, this company offers a rewarding environment for professionals looking to make a meaningful impact in the MedTech sector. Enjoy competitive salaries, opportunities for growth, and the chance to work on cutting-edge products that improve patient care.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist - MedTech (MDR/FDA)
✨Tip Number 1
Network like a pro! Reach out to your connections in the MedTech industry, especially those who are already in regulatory roles. A friendly chat can lead to insider info about job openings or even referrals.
✨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 how your experience aligns with the role's requirements.
✨Tip Number 3
Showcase your hands-on experience! During interviews, share specific examples of how you've contributed to regulatory strategies or compliance efforts in past roles. This will help you stand out as a candidate.
✨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 that extra step to connect with us directly.
We think you need these skills to ace Regulatory Affairs Specialist - MedTech (MDR/FDA)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with MDR and FDA frameworks, and don’t forget to showcase your skills in managing technical documentation. We want to see how you fit into our team!
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 the MedTech sector. Share specific examples of your past experiences that align with the responsibilities listed in the job description.
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 application is polished and professional.
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 our team at StudySmarter!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you brush up on the MDR and FDA regulations before your interview. Being able to discuss specific regulatory frameworks and how they apply to the role will show that you're not just familiar with the basics, but that you understand the nuances of the industry.
✨Showcase Your Documentation Skills
Prepare examples of technical documentation you've worked on in the past. Whether it's compliance reports or product documentation, being able to discuss your experience with ISO 13485 and other standards will demonstrate your hands-on expertise.
✨Highlight Cross-Functional Collaboration
This role requires working closely with various teams. Be ready to share examples of how you've successfully collaborated with different departments in previous roles. This will illustrate your ability to navigate a regulated environment effectively.
✨Stay Updated on Regulatory Changes
Regulatory affairs is always evolving, so show your enthusiasm for staying informed. Mention any recent changes in regulations that you've followed and how you think they might impact the business. This will reflect your proactive approach and commitment to the field.
