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- Tasks: Lead regulatory compliance for medical devices, ensuring products meet UK and MDR standards.
- Company: Join a growing medical device distributor with a flexible and innovative culture.
- Benefits: Flexible working hours, opportunity to shape your role, and career growth potential.
- Why this job: Make a real impact in the medical field while ensuring product safety and compliance.
- Qualifications: Experience in regulatory compliance within the medical device sector is essential.
- Other info: Dynamic SME environment with opportunities to influence and evolve compliance systems.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with an established and growing medical device distributor as they introduce their first dedicated regulatory compliance role. This is a newly created position within an SME environment, offering genuine flexibility to shape the role around the right individual.
As the new Regulatory Compliance Specialist, you will take ownership of distributor and supplier regulatory compliance across the product portfolio. Although the business is not the legal manufacturer, this role will be accountable for ensuring that all products placed on the market meet MDR and UK regulatory requirements, working directly with manufacturers and suppliers to manage compliance assurance and regulatory risk. This is a hands-on regulatory compliance role, firmly aligned to distributor and economic operator responsibilities.
The successful individual will sit at the interface between suppliers, customers, and internal commercial teams, ensuring regulatory compliance does not become a barrier to product supply or market access. Alongside core regulatory compliance activities, there is longer-term scope to support the evolution of the management system as the business evaluates a transition beyond ISO 9001.
Key responsibilities:- Lead distributor regulatory compliance activities in line with MDR, UK regulations, and applicable MHRA requirements.
- Act as the primary point of contact for regulatory compliance with manufacturers and suppliers, including confirmation of conformity, review of regulatory documentation, and ongoing supplier compliance monitoring.
- Ensure products are supported by appropriate declarations, labelling, instructions for use, and compliance documentation prior to placement on the market.
- Identify, assess, and manage regulatory compliance risks arising from suppliers, documentation gaps, or regulatory change.
- Manage customer and internal regulatory compliance queries, providing clear, pragmatic guidance from a distributor perspective.
- Support distributor relevant post-market activities, including complaint coordination, escalation to legal manufacturers, and vigilance related communications where applicable.
- Maintain regulatory compliance records and procedures relevant to the distributor role, including supplier and product documentation control.
- Contribute to the evaluation and potential transition towards ISO 13485 and other relevant standards, where appropriate.
- Monitor changes to MDR, UK regulations, and guidance, advising the business on impact to distributor obligations and product supply.
- Experience working in a regulatory, compliance, or RAQA role within the medical device sector, with direct exposure to distributor, importer, or supplier regulatory responsibilities.
- Strong working knowledge of MDR and UK medical device regulations from an economic operator perspective.
- Experience managing supplier compliance, including engagement with manufacturers on technical documentation, labelling, and conformity matters.
- Understanding of management systems, with ISO 9001 experience and exposure to ISO 13485 beneficial.
- Comfortable operating autonomously in a growing SME environment, with a pragmatic and commercially aware approach.
Regulatory Compliance Specialist employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Compliance Specialist
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. Building connections can open doors and give you insider info about job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory compliance needs and be ready to discuss how your experience aligns with their goals.
✨Tip Number 3
Showcase your hands-on experience in regulatory compliance during interviews. Use specific examples to demonstrate how you've managed compliance risks and worked with suppliers in the past.
✨Tip Number 4
Don’t forget to apply through our website! It’s a great way to ensure your application gets noticed, and we love seeing candidates who take that extra step.
We think you need these skills to ace Regulatory Compliance Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Compliance Specialist role. Highlight your experience in regulatory compliance within the medical device sector and any relevant knowledge of MDR and UK regulations. We want to see how your skills align 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 managed supplier compliance or navigated regulatory challenges in the past. We love a good story that showcases your expertise!
Showcase Your Problem-Solving Skills: In your application, don't forget to highlight your problem-solving abilities. This role involves managing compliance risks and providing guidance on regulatory queries, so share instances where you've successfully tackled similar challenges. We appreciate a proactive approach!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it shows you're keen on joining our team at StudySmarter!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you brush up on the latest MDR and UK medical device regulations. Being able to discuss specific compliance requirements and how they relate to the role will show that you're not just familiar with the basics, but that you’re ready to take ownership of regulatory compliance.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you've managed supplier compliance or dealt with regulatory documentation. Highlighting your hands-on experience will demonstrate your capability to handle the responsibilities of this new position effectively.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations regarding compliance risks or regulatory changes. Practise articulating your thought process and decision-making skills, as this will showcase your ability to navigate challenges in a pragmatic way.
✨Engage with the Interviewers
Don’t forget that interviews are a two-way street! Prepare thoughtful questions about the company’s approach to regulatory compliance and their future plans. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
