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- Tasks: Lead regulatory activities for innovative MedTech products from development to market launch.
- Company: Join a growing MedTech company focused on cutting-edge medical technology solutions.
- Benefits: Enjoy a hybrid work model with 4 days remote and 1 day in the office, plus potential for full remote.
- Why this job: Be at the forefront of medical innovation while making a real impact on healthcare.
- Qualifications: Experience in Medical Technology and strong regulatory knowledge, especially with FDA submissions.
- Other info: Collaborative environment with opportunities for professional growth and process improvement.
The predicted salary is between 36000 - 60000 £ per year.
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This range is provided by Eclectic Recruitment Ltd. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
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Senior Talent Solutions Specialist | Scientific & STEM Recruitment Lead | Life Science Headhunter & Market Insights
Senior Regulatory Affairs Specialist – MedTech
A growing MedTech company is seeking an experienced Senior/Lead Regulatory Affairs Specialist. The ideal candidate will act as the key liaison between the business, its products, and regulatory bodies, with responsibility across pre- and post-market regulatory activities.
We’re looking for someone with practical experience in Medical Technology (Wearables, Monitoring, Software as a Medical Device) quality and regulatory frameworks (including FDA submissions and international standards) who can guide products from development through to market launch and beyond.
Key responsibilities:
- Provide regulatory guidance to internal teams and senior management, supporting the preparation and submission of regulatory documentation.
- Maintain and update regulatory files and tracking systems to ensure timely access to approval and renewal information.
- Ensure products comply with regional and international regulations and standards.
- Keep abreast of evolving legislation, guidelines and industry practices.
- Analyse and present scientific data to support new product approvals and renewals.
- Manage submission timelines for licence variations and renewals, ensuring deadlines are met.
- Prepare and review product labels, patient information leaflets and related documentation.
- Advise on product testing requirements and interpret clinical and technical data.
- Offer strategic regulatory input during product development and updates.
- Lead or coordinate regulatory inspections and audits.
- Liaise and negotiate with regulatory authorities to secure product authorisations.
- Support process improvements and provide compliance training and advice to teams.
About You:
- Experience working within Medical Technology in a regulated environment, ideally including FDA 510(k) submissions and relevant international standards.
- Strong industry experience operating in a Senior/Lead level role within Regulatory Affairs.
- Proven ability to manage regulatory processes, from documentation through to communication with authorities.
- Strong analytical skills and the ability to clearly communicate complex technical and regulatory concepts.
- Collaborative, organised and able to manage multiple projects and deadlines.
This role works in a hybrid model with 4 days working from home, 1 day in the office. For the right candidate the company can offer a remote position with monthly office visits.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Medical Equipment Manufacturing
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Senior Regulatory Affairs Specialist employer: Eclectic Recruitment Ltd
Contact Detail:
Eclectic Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist
✨Tip Number 1
Network with professionals in the MedTech industry, especially those who have experience in regulatory affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks relevant to the role, such as FDA submissions and international standards. This knowledge will not only boost your confidence but also demonstrate your commitment to the field during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in managing regulatory processes. Be ready to share specific examples of how you successfully navigated challenges in regulatory submissions or compliance, as this will showcase your expertise.
✨Tip Number 4
Stay updated on evolving legislation and industry practices by following relevant publications and joining professional associations. This will help you engage in informed discussions during interviews and show that you are proactive in your professional development.
We think you need these skills to ace Senior Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly within the MedTech sector. Emphasise your familiarity with FDA submissions and international standards, as these are crucial for this role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about regulatory affairs in the MedTech industry. Mention specific projects or experiences that demonstrate your ability to manage regulatory processes and liaise with authorities.
Showcase Analytical Skills: Provide examples in your application that showcase your strong analytical skills. Discuss how you've successfully interpreted complex technical data or navigated regulatory frameworks in past roles.
Highlight Collaboration Experience: Since the role requires collaboration with internal teams and regulatory bodies, include examples of how you've worked effectively in team settings. Mention any leadership roles or initiatives where you guided teams through regulatory challenges.
How to prepare for a job interview at Eclectic Recruitment Ltd
✨Know Your Regulations
Familiarise yourself with the specific regulatory frameworks relevant to the MedTech industry, especially FDA submissions and international standards. Be prepared to discuss how your experience aligns with these regulations and how you can ensure compliance.
✨Showcase Your Analytical Skills
Prepare to demonstrate your ability to analyse and present scientific data effectively. Think of examples where you've successfully supported product approvals or renewals through data analysis, and be ready to explain your thought process.
✨Highlight Your Collaborative Experience
This role requires strong collaboration with internal teams and regulatory bodies. Share specific instances where you've worked cross-functionally to achieve regulatory goals, emphasising your communication skills and teamwork.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities in regulatory affairs. Think about challenges you've faced in past roles and how you navigated them, particularly regarding submission timelines and compliance issues.
