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For Companies At a Glance
- Tasks: Manage regulatory submissions and ensure timely market access for medical devices.
- Company: Join a leading firm in the life sciences sector, dedicated to innovation and compliance.
- Benefits: Enjoy flexible working options and a supportive corporate culture.
- Why this job: Be part of a dynamic team impacting global health through regulatory excellence.
- Qualifications: Minimum 5 years of experience in regulatory affairs and fluent in English required.
- Other info: Engage with cross-functional teams and participate in global inspections.
The predicted salary is between 43200 - 72000 £ per year.
What to Expect
- Establish and manage regulatory submission timelines for both new and existing products across key global markets.
- Prepare and file global medical device applications and amendments, ensuring timely market access.
- Engage with regulatory authorities and distribution partners to support product registrations.
- Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
- Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
- Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
- Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance.
- Review and approve product labeling to ensure compliance with global regulatory requirements.
- Support and participate in inspections and audits conducted by global regulatory authorities.
Requirements
- Minimum 5 years of Experience
- Fluent English
Regulatory Affairs – United Kingdom employer: Resourcing Life Science
Contact Detail:
Resourcing Life Science Recruiting Team
info@life-science.co.uk
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs – United Kingdom
✨Tip Number 1
Familiarise yourself with the latest EU MDR regulations and guidelines. Understanding these will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector. Attend industry conferences or webinars to connect with others who can provide insights and potentially refer you to opportunities at StudySmarter.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed regulatory submissions in the past. Highlighting your experience with global markets will show that you have the practical knowledge we’re looking for.
✨Tip Number 4
Research our company culture and values at StudySmarter. Tailoring your conversation during interviews to align with our mission can set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs – United Kingdom
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs position. Tailor your application to highlight relevant experience and skills that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in regulatory submissions, compliance, and working with international regulations. Use specific examples to demonstrate your expertise in managing timelines and engaging with regulatory authorities.
Craft a Strong Cover Letter: Your cover letter should not only express your interest in the role but also showcase your understanding of the regulatory landscape. Mention any specific achievements or projects that relate to the job, particularly those involving EU MDR compliance.
Proofread Your Application: Ensure that your application is free from errors. A well-written application reflects attention to detail, which is crucial in regulatory affairs. Consider asking a colleague or friend to review your documents before submission.
How to prepare for a job interview at Resourcing Life Science
✨Know Your Regulations
Familiarise yourself with the latest EU MDR regulations and any relevant international standards. Being able to discuss these confidently will show your expertise and commitment to compliance.
✨Demonstrate Cross-Functional Collaboration
Prepare examples of how you've worked with product development and manufacturing teams in the past. Highlighting your ability to integrate regulatory requirements throughout the product lifecycle will be crucial.
✨Showcase Your Experience
With a minimum of 5 years required, be ready to discuss specific projects or submissions you've managed. Use metrics or outcomes to illustrate your impact on market access and compliance.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in regulatory scenarios. Think about challenges you've faced and how you navigated them, especially regarding inspections and audits.
