Group Regulatory Lead

Group Regulatory Lead

Kingston upon Hull Full-Time 48000 - 72000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead regulatory compliance for innovative medical devices across multiple sites.
  • Company: A leading Class I Medical Device manufacturer with a remote-first culture.
  • Benefits: Competitive salary, private medical, pension, and flexible working.
  • Other info: Opportunity to grow your team and career in a dynamic environment.
  • Why this job: Make a real impact in healthcare while enjoying autonomy and remote work.
  • Qualifications: 5-10 years of regulatory experience in medical device design and manufacture.

The predicted salary is between 48000 - 72000 £ per year.

A Class i Medical Device manufacturer are hiring a Group Regulatory Lead.

It’s a predominantly remote role where you’ll get the autonomy to do things your way.

You will act as the group\’s regulatory subject matter expert, responsible for ensuring that all new and existing products meet applicable regulatory and safety requirements in all target markets across multiple sites.

You will guide teams on standards, risk management, technical documentation, and product safety, while rationalising and maintaining technical files.

There are five UK sites, all with their own quirks, some are doing things well, others need a bit more guidance. It’s all about having the character to educate, rather than police.

What you need to know:

💻 Mostly remote (you’ll barely leave your home office)

💰 £55–65k depending on experience

🩺 Private medical + pension

👤 This is a stand alone RA role, with scope to hire once you’re settled (1-2 hires)

What skills we need to see:

  • 5-10 years’ regulatory experience in medical device design & manufacture, minimum Class I, Class IIA would be advantageous.
  • Experience of working in a manufacturing environment in accordance with the requirements of ISO 13485, ISO 9001, ISO 14001 & the EU Medical Device Directive/ Medical Device Regulations.
  • Experience taking medical devices into new overseas markets.
  • Conversant with EU, APAC and most importantly the US/FDA.
  • Biocompatibility ISO 10993 experience would be the icing on the cake.

Although the role is remote, there will be occasional travel to the clients manufacturing facilities. Given their locations, someone based Midlands or above, would be preferable.

Group Regulatory Lead employer: Medibeam

As a leading Class I Medical Device manufacturer, we pride ourselves on fostering a supportive and flexible work environment that empowers our employees to thrive. With a predominantly remote role, you will enjoy the autonomy to shape your work while benefiting from competitive compensation, private medical insurance, and opportunities for professional growth. Our collaborative culture encourages knowledge sharing and mentorship, making it an ideal place for those looking to make a meaningful impact in the regulatory landscape of medical devices.
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Contact Detail:

Medibeam Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Group Regulatory Lead

✨Tip Number 1

Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Group Regulatory Lead role. You never know who might have the inside scoop on openings or can put in a good word for you.

✨Tip Number 2

Prepare for those interviews by brushing up on your regulatory knowledge. Make sure you can confidently discuss ISO standards and the EU Medical Device Regulations. We want you to shine as the subject matter expert they’re looking for!

✨Tip Number 3

Showcase your experience with technical documentation and risk management during interviews. Bring examples of how you've guided teams in the past, especially in tricky situations. This will demonstrate your ability to educate rather than police, which is key for this role.

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take that extra step to connect with us directly.

We think you need these skills to ace Group Regulatory Lead

Regulatory Expertise
Medical Device Design
ISO 13485
ISO 9001
ISO 14001
EU Medical Device Directive
Medical Device Regulations
Market Entry Strategy
Familiarity with FDA Regulations
Biocompatibility ISO 10993
Risk Management
Technical Documentation
Product Safety
Team Guidance and Education

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Group Regulatory Lead role. Highlight your regulatory experience in medical devices, especially Class I and IIA, and any relevant ISO standards you've worked with. We want to see how your background fits perfectly 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 the perfect fit for this role. Share specific examples of how you've guided teams in regulatory matters and how you’ve tackled challenges in a manufacturing environment. We love a good story!

Showcase Your Autonomy: Since this role offers a lot of autonomy, make sure to mention instances where you've successfully managed projects independently. We’re looking for someone who can take initiative and educate others rather than just enforce rules. Let us know how you’ve done this in the past!

Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy – just a few clicks and you’re done!

How to prepare for a job interview at Medibeam

✨Know Your Regulations

Brush up on the specific regulations and standards relevant to Class I medical devices, especially ISO 13485 and the EU Medical Device Regulations. Being able to discuss these confidently will show that you’re not just familiar with the requirements but can also apply them effectively.

✨Showcase Your Experience

Prepare to share specific examples from your past roles where you successfully navigated regulatory challenges or improved compliance processes. Highlighting your experience in taking medical devices into new markets will demonstrate your capability to handle the responsibilities of this role.

✨Emphasise Your Educational Approach

Since the role requires guiding teams rather than policing them, be ready to discuss how you’ve educated colleagues on regulatory matters in the past. Share anecdotes that illustrate your ability to foster a collaborative environment while ensuring compliance.

✨Be Ready for Remote Work Dynamics

As this is predominantly a remote role, think about how you manage your time and communicate effectively in a virtual setting. Prepare to discuss tools and strategies you use to stay organised and connected with teams across different sites.

Group Regulatory Lead
Medibeam
Location: Kingston upon Hull
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