At a Glance
- Tasks: Lead regulatory compliance and Post Market Surveillance for medical devices.
- Company: Join a fast-growing global medical device organisation with a supportive culture.
- Benefits: Hybrid work, high-impact role, and opportunities for professional growth.
- Other info: Collaborative team environment with ownership and visibility in your role.
- Why this job: Make a real difference in patient safety and product innovation.
- Qualifications: Degree in Science, Medical, or Engineering and 3+ years in Regulatory Affairs.
The predicted salary is between 40000 - 50000 £ per year.
Join a growing global medical devices business and take ownership of regulatory compliance across key markets. We’re looking for an experienced Regulatory Affairs professional to lead Post Market Surveillance (PMS) activities and support global regulatory submissions across EU, UK, US, and international markets.
Key Responsibilities:
- Lead Post Market Surveillance (PMS): PMS Plans, PSUR, PMCF documentation
- Prepare and maintain Technical Files / Technical Documentation (EU MDR)
- Support Regulatory Submissions: MHRA, FDA, GUDID, FURLS
- Ensure compliance with EU MDR, UK MDR, FDA, ISO 13485, ISO 14971
- Partner cross-functionally on New Product Development (NPD)
- Support QMS, audits, vigilance, and complaints handling
- Review labelling, packaging, and IFUs for regulatory compliance
Requirements:
- Degree in Science, Medical, or Engineering discipline
- 3 years or more Regulatory Affairs experience (Medical Devices)
- Strong experience in Post Market Surveillance & Clinical Evaluation
- Proven ability with Technical Documentation / Dossiers
- Knowledge of global regulatory frameworks (EU, UK, US)
- Highly organised, detail-driven, and confident managing multiple priorities
Why GBUK?
- Global, fast-growing medical device organisation
- High-impact role with ownership and visibility
- Collaborative, supportive team culture
- Opportunity to influence patient safety and product innovation
Apply now or get in touch to find out more.
Senior Regulatory and Post Market Affairs Associate in Hemel Hempstead employer: GBUK
GBUK Group is an exceptional employer, offering a dynamic and collaborative work environment in Selby, North Yorkshire. With a strong focus on employee growth and development, we provide opportunities for our team members to take ownership of impactful projects in the medical devices sector, ensuring compliance and innovation that directly influences patient safety. Join us to be part of a fast-growing global organisation where your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory and Post Market Affairs Associate in Hemel Hempstead
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR, UK MDR, and FDA regulations. We want you to feel confident discussing your experience with Post Market Surveillance and Technical Documentation.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed multiple priorities in past roles. This will highlight your ability to thrive in a fast-paced environment like ours.
✨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 genuinely interested in joining our team.
We think you need these skills to ace Senior Regulatory and Post Market Affairs Associate in Hemel Hempstead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory & Post Market Affairs Associate role. Highlight your experience in regulatory compliance, especially with EU MDR and FDA submissions, as well as your skills in Post Market Surveillance.
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 aligns with our mission at GBUK Group. Don’t forget to mention specific achievements that demonstrate your expertise.
Showcase Your Organisational Skills:Since this role requires managing multiple priorities, make sure to highlight your organisational skills in your application. Share examples of how you've successfully juggled tasks in previous roles, particularly in a regulatory context.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to attach all your documents in one go. Plus, we love seeing applications come through our own platform!
How to prepare for a job interview at GBUK
✨Know Your Regulations
Make sure you brush up on the key regulations like EU MDR, UK MDR, and FDA guidelines. Being able to discuss these confidently will show that you’re not just familiar with the requirements but also passionate about compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully led Post Market Surveillance activities or managed regulatory submissions. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Understand the Company’s Products
Do some homework on GBUK Group and their product range. Knowing their medical devices and any recent news can help you tailor your responses and demonstrate your genuine interest in the role and the company.
✨Ask Insightful Questions
Prepare thoughtful questions about the team culture, challenges in regulatory affairs, or upcoming projects. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
