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For Companies At a Glance
- Tasks: Ensure product compliance with regulations and prepare necessary documentation.
- Company: Join a dynamic team focused on medical device innovation and quality assurance.
- Benefits: Enjoy flexible working options and opportunities for professional growth.
- Why this job: Be part of a crucial role that impacts product safety and quality in healthcare.
- Qualifications: 2+ years in Medical Device Regulatory Affairs or related fields required.
- Other info: Ideal for detail-oriented individuals passionate about compliance and quality.
The predicted salary is between 28800 - 48000 £ per year.
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to join our team, with at least 2 years’ experience in Medical Device Regulatory Affairs, Post Market Surveillance, Quality Assurance or Design Control or related function. In this role, you will be responsible for ensuring that our products comply with all regulatory requirements and standards. You will play a crucial part in the development and maintenance of regulatory submissions, working closely with various departments to facilitate compliance and quality assurance throughout the product lifecycle.
Responsibilities
- Prepare and submit regulatory documents to relevant authorities in accordance with established guidelines.
- Review product labels, promotional materials, and technical documentation for compliance with regulatory standards.
- Liaise with internal teams, including Quality Assurance and Research & Development, to ensure that all aspects of product development meet regulatory requirements.
- Monitor changes in regulations and assess their impact on existing products and processes.
- Conduct audits of documentation and processes to ensure compliance with internal policies and external regulations.
- Provide training and guidance to staff on regulatory requirements and best practices.
- Assist in the preparation for regulatory inspections and audits by maintaining accurate records and documentation.
Skills
- Strong understanding of regulatory frameworks relevant to the industry, including quality assurance principles.
- Excellent attention to detail with strong analytical skills for reviewing complex documents.
- Ability to communicate effectively both verbally and in writing, presenting information clearly to diverse audiences.
- Proficient in using regulatory databases and document management systems.
- Strong organisational skills with the ability to manage multiple projects simultaneously while meeting deadlines.
- A proactive approach to problem-solving, with the ability to work independently as well as part of a team.
If you are passionate about ensuring product compliance and have a keen eye for detail, we invite you to apply for this exciting opportunity as a Regulatory Affairs Specialist.
Regulatory Affairs Specialist employer: CELOX Medical
Contact Detail:
CELOX Medical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks relevant to medical devices. Understanding the nuances of these regulations 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, especially those who have experience in medical devices. Engaging with industry experts can provide insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Stay updated on recent changes in regulations and compliance standards. Being knowledgeable about current trends will show your proactive approach and dedication to the field during discussions with our team.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you ensured compliance or improved processes. Real-life scenarios can effectively showcase your skills and fit for the Regulatory Affairs Specialist role.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Medical Device Regulatory Affairs, Post Market Surveillance, and Quality Assurance. Use specific examples that demonstrate your understanding of regulatory frameworks and compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your attention to detail. Mention how your skills align with the responsibilities outlined in the job description, such as preparing regulatory documents and liaising with internal teams.
Highlight Relevant Experience: In your application, emphasise any previous roles where you prepared regulatory submissions or conducted audits. Detail your experience with regulatory databases and document management systems, as these are crucial for the role.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. Ensure that your communication is clear and professional, reflecting the strong analytical skills required for the position.
How to prepare for a job interview at CELOX Medical
✨Know Your Regulations
Familiarise yourself with the specific regulatory frameworks relevant to the medical device industry. Be prepared to discuss how these regulations impact product development and compliance, as this will demonstrate your expertise and understanding of the role.
✨Showcase Your Attention to Detail
Since the role requires a strong attention to detail, be ready to provide examples from your past experience where your meticulousness made a difference. This could include instances where you identified compliance issues or improved documentation processes.
✨Communicate Clearly
Effective communication is key in this role. Practice articulating complex regulatory concepts in a clear and concise manner. You might be asked to explain how you would present regulatory information to different teams, so think about how to tailor your message for various audiences.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle regulatory challenges. Think of situations where you had to navigate regulatory changes or conduct audits, and be ready to discuss your approach and the outcomes.
