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- Tasks: Join a global team to ensure life-saving medical devices meet regulatory standards.
- Company: Work with a leading Medical Device company focused on emergency products.
- Benefits: Enjoy a fully remote position with flexible work options across the UK and EU.
- Why this job: Make a real impact by contributing to global regulatory strategies for essential products.
- Qualifications: Must have proven experience in Regulatory Affairs within the Medical Device sector.
- Other info: This is an initial 6-month Fixed Term Contract with potential for growth.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent is delighted to be partnered with a global Medical Device company, specialising in emergency medical products, who due to their exceptional continued growth, have an exciting opportunity for Regulatory Affairs Specialist to join them on an initial 6-month Fixed Term Contract. This is a fully remote position and can be based anywhere in the United Kingdom or European Union. As their new Regulatory Affairs Specialist, you will play a pivotal role in Product Registrations across the EU and Rest of the World, contributing to the global regulatory strategy for a portfolio of life-saving products. To be successful as their new Regulatory Affairs Specialist, you will have proven Regulatory Affairs experience in the Medical Device sector with a variety of classes of Medical Device and extensive experience in EU & RoW Medical Device Product Registrations. Key Responsibilities Work with internal teams and external regulators to ensure ongoing product compliance with applicable standards and regulations. Register medical devices in new international markets and maintain existing registrations. Assist in the review and maintenance of technical product files, including the ongoing MDR transition. Collaborate with design engineers to produce essential technical documentation, such as risk assessments and test reports. Provide regulatory documentation support to the Sales team for market registrations. Partner with authorities, Notified Bodies, and other national regulators on company and product registrations. Support regulatory requirements for CAPAs, NCRs, and customer complaints. Experience and Skills Required Proven Regulatory Affairs experience within the Medical Device sector Extensive experience with global product registrations for the UK, EU and Rest of World Knowledge of medical device standards, including ISO 13485, and familiarity with Medical Device Regulations. Experience of a variety of classes of Medical Devices, preferably Class IIa & IIb If you have the skills and experience needed to be successful in this role, please get in touch with Kris Holmes today!
Regulatory Affairs Specialist employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarize yourself with the specific medical device regulations and standards, especially ISO 13485. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the Regulatory Affairs field, particularly those who have experience with medical devices. Engaging with industry groups or forums can provide valuable insights and connections that may lead to job opportunities.
✨Tip Number 3
Stay updated on the latest trends and changes in medical device regulations across the EU and RoW. Being knowledgeable about current events in the industry can give you an edge during discussions with potential employers.
✨Tip Number 4
Prepare to discuss specific examples of your past experiences with product registrations and compliance challenges. Highlighting your problem-solving skills and successful outcomes will make a strong impression during interviews.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Specialist position. Understand the key responsibilities and required skills, especially focusing on the experience in Medical Device regulations and product registrations.
Tailor Your CV: Customize your CV to highlight your relevant experience in Regulatory Affairs within the Medical Device sector. Emphasize your familiarity with EU & RoW product registrations and any specific classes of medical devices you have worked with.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific examples of your past work that align with the responsibilities outlined in the job description.
Highlight Relevant Certifications: If you have any certifications related to regulatory affairs or medical devices, make sure to include them in your application. This can strengthen your candidacy and demonstrate your commitment to the field.
How to prepare for a job interview at Cure Talent
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of medical device regulations, especially ISO 13485 and the MDR transition. Be prepared to discuss how you've applied this knowledge in previous roles.
✨Demonstrate Experience with Product Registrations
Prepare examples of your experience with global product registrations, particularly in the UK, EU, and RoW. Discuss specific challenges you faced and how you overcame them.
✨Collaborative Mindset
Since the role involves working with internal teams and external regulators, emphasize your ability to collaborate effectively. Share instances where teamwork led to successful outcomes in regulatory affairs.
✨Be Ready for Technical Discussions
Expect questions about technical documentation, such as risk assessments and test reports. Brush up on these topics and be ready to explain how you’ve contributed to creating or reviewing such documents.
