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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, competitive salary, and opportunities for professional growth.
- Why this job: Shape the future of regulatory compliance in a dynamic SME environment.
- Qualifications: Experience in regulatory roles within the medical device sector and knowledge of MDR.
- Other info: Opportunity to influence compliance strategies and transition towards ISO 13485.
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 in Watford employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Compliance Specialist in Watford
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device sector on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Regulatory Compliance Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDR and UK regulations. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during those all-important conversations.
✨Tip Number 3
Don’t just wait for job postings! Reach out directly to companies you admire, even if they’re not advertising a role. We believe showing initiative can set you apart and might just lead to an opportunity that’s not yet on the market.
✨Tip Number 4
Utilise our website to apply for roles directly. We’ve made it super easy for you to find positions that match your skills and interests. Plus, applying through us means you’ll get the latest updates and tips tailored just for you!
We think you need these skills to ace Regulatory Compliance Specialist in Watford
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, especially within the medical device sector, and showcase any relevant skills that align with the job description.
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. Mention specific experiences that demonstrate your understanding of MDR and UK regulations, and how you can contribute to the team.
Showcase Your Problem-Solving Skills: In your application, don’t forget to highlight your ability to manage compliance risks and provide clear guidance. Share examples of how you've tackled challenges in previous roles, especially those related to supplier compliance or regulatory changes.
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 this exciting opportunity. Plus, it shows you’re keen on joining our team!
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.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the company’s compliance processes and future plans. Inquiring about their approach to transitioning towards ISO 13485 can illustrate your forward-thinking mindset and genuine interest in the role.
✨Demonstrate Your Pragmatic Approach
Be ready to discuss how you balance regulatory compliance with commercial needs. Sharing examples of how you've navigated compliance challenges without hindering product supply will highlight your ability to operate effectively in an SME environment.
