At a Glance
- Tasks: Ensure regulatory compliance for life-changing medical devices and support technical documentation.
- Company: Join a growing medical device organisation with a collaborative culture.
- Benefits: Competitive salary, career development opportunities, and flexible working arrangements.
- Other info: Opportunity for national and international travel and exposure to diverse teams.
- Why this job: Make a real impact in the medical field while working with international regulations.
- Qualifications: 2+ years in Regulatory Affairs or Quality, strong attention to detail, and technical writing skills.
The predicted salary is between 42000 - 44000 £ per year.
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
- Support the preparation and maintenance of MDR Technical Documentation (Annex II & 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
This role is primarily office-based with some flexibility for remote working. Occasional national and international travel may be required.
Regulatory Affairs Associate in Gloucester employer: HAWK3 Talent Solutions
Join a forward-thinking medical device organisation in Gloucester, where you will thrive in a collaborative and supportive culture that prioritises employee growth and development. With opportunities for career advancement within Regulatory Affairs and exposure to international regulatory activities, this role offers a meaningful chance to contribute to 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. Bring examples of your past work, like technical documentation you’ve prepared. We want to see how you ensure compliance and quality in your projects!
✨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 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 MDR, ISO standards, and any relevant technical documentation skills. We want to see how your background aligns with 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 in the medical device sector. Share specific examples of your past experiences that relate to the responsibilities listed in the job description.
Showcase Your Attention to Detail:Since this role requires excellent attention to 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 through our website for the best chance of being noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at HAWK3 Talent Solutions
✨Know Your Regulations
Make sure you brush up on the latest regulations like MDR, MDD, and ISO standards. Being able to discuss these confidently will show that you're not just familiar with the basics but are genuinely invested in the field.
✨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.
✨Understand the Company’s Products
Do some homework on the company’s medical devices and their regulatory pathways. This knowledge will help you answer questions more effectively and show that you’re proactive about understanding their business.
✨Prepare for Cross-Functional Questions
Since the role involves working with various teams, be ready to discuss how you've collaborated with Quality, Engineering, and other departments in the past. Highlighting your teamwork skills will be key to impressing the interviewers.
