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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 regulatory compliance.
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.
Locations
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. Attend industry conferences or webinars to make connections and gain insights that could be beneficial during the application process.
✨Tip Number 3
Stay updated on recent changes in regulations and compliance standards. Being knowledgeable about current trends will show potential employers that you are proactive and dedicated to continuous learning in your field.
✨Tip Number 4
Prepare for potential interviews by practising how to articulate your experience with regulatory submissions and compliance processes. Use specific examples from your past roles to illustrate your expertise and problem-solving skills.
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 attention to detail and analytical skills.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory compliance and detail how your background aligns with the responsibilities of the role. Mention your ability to liaise with various departments and your proactive problem-solving approach.
Highlight Relevant Skills: Clearly outline your understanding of regulatory frameworks and quality assurance principles. Emphasise your organisational skills and ability to manage multiple projects, as these are crucial for the role.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no spelling or grammatical errors, as attention to detail is key in this field. A polished application reflects your professionalism.
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 meticulous nature helped ensure compliance or improved quality assurance. This could include specific projects or audits you've conducted.
✨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
Anticipate scenario-based questions that assess your problem-solving skills and ability to handle regulatory challenges. Think of situations where you had to adapt to changing regulations or resolve compliance issues, and be ready to discuss your approach and outcomes.
