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- Tasks: Support post market surveillance and ensure global regulatory compliance for medical devices.
- Company: Leading global medical devices company with a collaborative culture.
- Benefits: Competitive salary, benefits package, and opportunities for career growth.
- Other info: Dynamic environment with exposure to global markets and cross-functional teams.
- Why this job: Make a real impact in regulatory affairs while working on innovative medical products.
- Qualifications: Experience in medical devices and strong understanding of regulatory frameworks.
The predicted salary is between 45000 - 55000 £ per year.
This is a key position within a Regulatory Affairs team, supporting post market surveillance activities, technical documentation, and global regulatory compliance. You’ll work closely with cross-functional teams and senior leadership, contributing to both ongoing product compliance and new product development. The role offers a broad scope across EU MDR, UK regulations, and international markets, with involvement in audits, submissions, and regulatory strategy.
You will:
- Prepare, maintain, and schedule post market surveillance documentation, including PMS plans and reports
- Support post market clinical follow-up activities and documentation
- Contribute to technical documentation and regulatory dossier preparation for EU MDR and other global markets
- Liaise with internal teams to ensure regulatory compliance across product lifecycle activities
- Assist with regulatory submissions, registrations, and maintenance of approvals
- Support internal and external audits, including QMS activities
- Provide regulatory input into new product development projects
- Maintain regulatory databases (e.g. MHRA, FDA, GUDID)
- Review and approve packaging, labelling, and product literature
- Support vigilance, complaints handling, and post market activities alongside Quality teams
Experience and qualities that make you a strong fit:
- Solid experience within the medical device industry
- Strong background in post market surveillance and documentation
- Experience preparing or maintaining technical dossiers
- Good understanding of MDR, MDD, UK MDR, IVDR/IVDD and relevant ISO standards
- Strong organisational skills with the ability to manage multiple priorities
Preferred:
- Experience with post market clinical follow-up (PMCF)
- Exposure to internal and external audits
- Knowledge of clinical evaluation and risk management (ISO 14971)
What’s on offer:
- Opportunity to work in a collaborative, growing regulatory team
- Exposure to global regulatory frameworks and submissions
- Involvement in both lifecycle management and new product development
- A varied role with strong cross-functional interaction
If you’re looking to take the next step in your regulatory career within a dynamic medical device environment, this could be a great opportunity to broaden your experience and make a real impact.
Senior Regulatory Affairs Associate employer: Carrot Recruitment
Contact Detail:
Carrot Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and UK regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your experience with post market surveillance and technical documentation during interviews. We suggest using specific examples from your past roles to demonstrate your skills and how they align with the job requirements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your background in post market surveillance and any relevant regulatory experience to catch our eye!
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for this role. Share specific examples of your past work in regulatory affairs and how it aligns with what we’re looking for.
Showcase Your Organisational Skills: Since this role involves managing multiple priorities, give us a glimpse of how you stay organised. Mention any tools or methods you use to keep track of your tasks and deadlines.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Carrot Recruitment
✨Know Your Regulations
Make sure you brush up on the latest EU MDR, UK regulations, and ISO standards relevant to the role. Being able to discuss these confidently will show that you're not just familiar with the basics but are also ready to tackle the complexities of regulatory affairs.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in post market surveillance and technical documentation. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Understand the Company’s Products
Do some homework on the company’s product range and recent developments in their regulatory strategies. This will help you ask insightful questions and demonstrate your genuine interest in contributing to their success.
✨Prepare for Cross-Functional Collaboration
Since the role involves liaising with various teams, think about how you can illustrate your teamwork skills. Be ready to discuss how you've successfully collaborated with different departments in the past to achieve regulatory compliance.