At a Glance
- Tasks: Ensure regulatory compliance for life-changing medical devices and support technical documentation.
- Company: Dynamic medical device organisation with a collaborative culture.
- Benefits: Competitive salary, career development, and exposure to international regulations.
- Other info: Flexible working options and opportunities for international travel.
- Why this job: Join a growing team and make a real impact in the medical field.
- Qualifications: 2+ years in Regulatory Affairs or Quality, with strong attention to detail.
The predicted salary is between 42000 - 44000 £ per year.
Office-based (with some flexibility) Occasional national and international travel Salary: A GBP 42,000 - A GBP 44,000 Location: Gloucester
We are looking for a detail-driven and motivated Regulatory Affairs Associate to join a growing and dynamic team within the medical devices sector. This is a fantastic opportunity to play a key role in ensuring regulatory compliance across international markets, supporting the development of life-changing products while working in a highly collaborative, quality-focused environment.
The Role
Reporting into the Regulatory Affairs function, you will play a key role in maintaining compliance with international medical device regulations and supporting the creation and maintenance of technical documentation.
Key Responsibilities
- Support the preparation and maintenance of MDR Technical Documentation (Annex II and III)
- Assist with Class IIa conformity assessments and Notified Body interactions
- Support UK and international regulatory registrations including MHRA, FDA, Canada, and Australia
- Maintain regulatory documentation in line with ISO 13485 and ISO 14971 requirements
- Support post-market surveillance, vigilance, and PMCF activities
- Review labelling, IFUs, and promotional materials for regulatory compliance
- Work cross-functionally with Quality, Engineering, Manufacturing, and Commercial teams
- Support internal, customer, and external audits
- Assist with UDI management, EUDAMED registrations, and regulatory change activities
About You
- Minimum 2 years experience within Regulatory Affairs or Quality in the medical device industry
- Good understanding of MDR, MDD, ISO 13485, and FDA 21 CFR Part 820
- Experience supporting technical documentation and regulatory submissions
- Strong technical writing and document control skills
- Excellent attention to detail and analytical capability
- Confident working across multiple stakeholders and departments
- Internal auditing experience would be advantageous
- Experience with Class IIa medical devices and eQMS systems is desirable
What's on Offer
- Opportunity to join a growing medical device organisation
- Collaborative and supportive culture
- Exposure to international regulatory activities
- Career development opportunities within Regulatory Affairs
Closing date is 27th June 2026.
Regulatory Affairs Associate in Gloucester employer: TipTopJob
Join a forward-thinking medical device organisation in Gloucester, where you will thrive in a collaborative and supportive culture that values your contributions. With opportunities for career development and exposure to international regulatory activities, this role as a Regulatory Affairs Associate offers a meaningful pathway to impact life-changing products while enjoying a flexible work environment and competitive salary.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Associate in Gloucester
✨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 MDR, ISO standards, and recent regulatory changes. We recommend practising common interview questions with a friend to boost your confidence.
✨Tip Number 3
Showcase your attention to detail! During interviews, share specific examples of how you’ve maintained compliance or improved documentation processes. We love hearing about real-life experiences!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals to join our team in making a difference in the medical device sector.
We think you need these skills to ace Regulatory Affairs Associate in Gloucester
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight your experience with medical devices and any relevant regulations like MDR and ISO standards. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a great fit for our team. Keep it concise but engaging – we love a good story!
Showcase Your Attention to Detail:Since this role requires a keen eye for detail, make sure your application is free from typos and errors. We appreciate candidates who take the time to ensure their documents are polished and professional.
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’re considered for the role. Plus, it’s super easy – just follow the prompts!
How to prepare for a job interview at TipTopJob
✨Know Your Regulations
Make sure you brush up on the key regulations like MDR, MDD, and ISO standards relevant to the role. Being able to discuss these confidently will show that you're not just familiar with the terms but understand their implications in the medical device sector.
✨Showcase Your Technical Writing Skills
Prepare examples of your technical documentation work. Whether it's MDR Technical Documentation or labelling reviews, having concrete examples ready will demonstrate your expertise and attention to detail, which are crucial for this position.
✨Understand the Company’s Products
Research the company’s product range and any recent developments in their regulatory affairs. This knowledge will help you tailor your answers and show genuine interest in how you can contribute to their mission of delivering life-changing products.
✨Prepare for Cross-Functional Collaboration
Think about your experiences working with different teams, such as Quality, Engineering, and Manufacturing. Be ready to share specific instances where you successfully collaborated across departments, as this role requires strong teamwork skills.
