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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 hybrid work model with 3 days in the office.
- Why this job: Make a real impact on product quality and safety while collaborating with diverse teams.
- Qualifications: 2+ years in Medical Device Regulatory Affairs or related fields required.
- Other info: Must have the right to work in the UK; no visa sponsorship available.
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.
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 events or join online forums to gain insights and potentially get referrals that could lead to job opportunities.
✨Tip Number 3
Stay updated on recent changes in regulations and compliance standards. Being knowledgeable about current trends will show your proactive approach and readiness to adapt, which is crucial for a Regulatory Affairs Specialist.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you ensured compliance or improved processes. This will highlight your practical skills and problem-solving abilities during the interview process.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of a Regulatory Affairs Specialist. Familiarise yourself with the key skills mentioned in the job description, such as knowledge of regulatory frameworks and quality assurance principles.
Tailor Your CV: Customise your CV to highlight relevant experience in Medical Device Regulatory Affairs, Post Market Surveillance, or Quality Assurance. Use specific examples that demonstrate your attention to detail and analytical skills, as these are crucial for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory compliance and your understanding of the industry. Mention how your previous experiences align with the responsibilities outlined in the job description, and express your enthusiasm for the opportunity.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your writing is clear and concise, as effective communication is essential for this role.
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 standards, as well as any recent changes that could impact the role.
✨Showcase Your Attention to Detail
Prepare to discuss specific examples where your attention to detail made a difference in your previous roles. Highlight experiences where you reviewed complex documents or ensured compliance with regulatory standards.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. You may need to explain complex regulatory concepts to non-experts, so demonstrating your ability to communicate effectively is key.
✨Demonstrate Proactivity
Be ready to share instances where you took the initiative to solve problems or improve processes. Regulatory Affairs often requires a proactive approach, so showcasing this trait will set you apart.
