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- Tasks: Ensure product compliance with regulations and prepare submissions.
- Company: Join a dynamic team focused on medical device innovation.
- Benefits: Enjoy a collaborative work environment with opportunities for growth.
- Why this job: Make a real impact in healthcare while developing your regulatory expertise.
- Qualifications: 2+ years in Medical Device Regulatory Affairs or related fields required.
- Other info: Office presence needed 3 days a week in Crewe, Cheshire.
The predicted salary is between 36000 - 60000 £ 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.
Please note there is a requirement to be in the office 3 days per week in Crewe, Cheshire.
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.
- 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.
Please note you must have the right to work in the UK as we do not offer any Visa sponsorship.
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 events or join online forums to gain insights and potentially get referrals.
✨Tip Number 3
Prepare to discuss real-life scenarios where you've ensured compliance or improved processes in previous roles. Having concrete examples ready will showcase your expertise and problem-solving skills.
✨Tip Number 4
Research StudySmarter's products and their regulatory needs. Tailoring your conversation to how your skills can specifically benefit our team will make a strong impression during the interview process.
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 to demonstrate your skills and achievements relevant to the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the industry. Mention how your background aligns with the responsibilities outlined in the job description.
Highlight Relevant Skills: In your application, emphasise your strong attention to detail, analytical skills, and ability to communicate effectively. These are crucial for the role and should be evident in your written materials.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential for a Regulatory Affairs Specialist.
How to prepare for a job interview at CELOX Medical
✨Know Your Regulations
Make sure you have a solid understanding of the regulatory frameworks relevant to medical devices. Brush up on the latest regulations and be prepared to discuss how they impact product compliance.
✨Showcase Your Attention to Detail
As a Regulatory Affairs Specialist, attention to detail is crucial. Be ready to provide examples from your past experience where your meticulous nature helped ensure compliance or improved processes.
✨Communicate Clearly
Effective communication is key in this role. Practice articulating complex regulatory concepts in a clear and concise manner, as you may need to explain these to various stakeholders during the interview.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about past challenges you've faced in regulatory affairs and how you navigated them, as this will demonstrate your proactive approach.
