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- Tasks: Join our team as a Regulatory Associate, ensuring compliance for medical devices.
- Company: We're a dynamic company focused on innovation in the medical device sector.
- Benefits: Enjoy hybrid work options and a collaborative team environment.
- Why this job: Make a real impact on patient safety and global access to medical devices.
- Qualifications: Degree in science or engineering; experience with medical device regulations required.
- Other info: Opportunity to lead compliance processes and participate in audits.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Regulatory Associate – Medical DevicesLocation: West London/ Berkshire (Hybrid or On-site, depending on candidate location)Employment Type: Full-TimeAre you looking to advance your career in Regulatory Affairs within a fast-paced and impactful medical device environment? We’re hiring a Regulatory Associate to join a highly collaborative RA/QA team and play a central role in global product compliance and regulatory strategy execution.This is an exciting opportunity for someone with strong knowledge of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485, who thrives on autonomy, ownership, and making a real contribution to patient safety and product success.Key ResponsibilitiesPrepare and maintain global regulatory submissions and renewalSupport external distributors, authorised reps, and internal teams on regulatory mattersCompile and maintain MDR-compliant Technical Files and related documentationLead the transition of existing MDD Technical Files to MDR formatManage post-market surveillance activities and clinical evaluation maintenanceConduct and support complaint trend analysis and ensure accurate reportingMonitor changes in global regulatory frameworks and advise management accordinglyParticipate in external audits (e.g. Notified Body) and host internal auditsReview and approve product, labelling, and process changes for regulatory impactEnsure full regulatory compliance in EU, US, and other territories as requiredLiaise with Notified Bodies and coordinate Technical File auditsCandidate ProfileDegree (2:1 or above) in a scientific or engineering disciplineProven experience working with Medical Devices under 93/42/EEC and MDR 2017/745Strong understanding of CE Marking, ISO 13485, ISO 14971, and GMPFamiliar with medical device labelling (ISO 15223) and Essential Requirements ChecklistsExperience liaising with Notified Bodies and supporting auditsConfident in authoring and maintaining Declarations of Conformity and Technical FilesHighly organised, hands-on, and commercially astuteExcellent communication, analytical, and problem-solving skillsAbility to work independently and collaboratively in cross-functional teamsWhy Apply?You’ll be joining a passionate team that values quality, innovation, and continuous improvement. This role offers a unique opportunity to shape compliance processes and directly impact global patient access to life-enhancing medical devices.To apply, please submit your CV and a short cover note outlining your suitability. For a confidential discussion about the role, feel free to get in touch directly.
Regulatory Specialist employer: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist
✨Tip Number 1
Familiarise yourself with the latest updates on the Medical Device Directive and EU MDR regulations. Being well-versed in these areas will not only boost your confidence during discussions but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about best practices that can set you apart.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to regulatory compliance in previous roles. Highlighting your hands-on experience with Technical Files and audits will show that you can hit the ground running in this position.
✨Tip Number 4
Research StudySmarter's values and recent projects related to regulatory affairs. Tailoring your conversation to align with our mission and demonstrating how you can contribute to our goals will make a strong impression during any discussions.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Specialist position. Familiarise yourself with the Medical Device Directive, EU MDR, and ISO standards mentioned in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the job description. Emphasise your knowledge of regulatory compliance, technical file management, and any experience with Notified Bodies.
Craft a Compelling Cover Note: Write a concise cover note that clearly outlines your suitability for the role. Mention specific experiences that demonstrate your understanding of regulatory affairs and your ability to contribute to patient safety and product success.
Proofread Your Application: Before submitting, carefully proofread your CV and cover note for any errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at LinkedIn
✨Know Your Regulations
Make sure you have a solid understanding of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485. Be prepared to discuss how these regulations impact your previous work and how you can apply this knowledge in the new role.
✨Showcase Your Experience
Highlight your experience with regulatory submissions, Technical Files, and liaising with Notified Bodies. Use specific examples from your past roles to demonstrate your expertise and how it aligns with the responsibilities of the Regulatory Associate position.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle regulatory challenges. Prepare scenarios where you successfully navigated compliance issues or improved processes, as this will showcase your analytical abilities.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategies and how they approach compliance. This shows your genuine interest in the role and helps you understand how you can contribute to their goals.
