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- Tasks: Manage regulatory submissions for medical devices globally and ensure timely approvals.
- Company: Join an exciting firm expanding its regulatory function in the medical device industry.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be part of a team that impacts global health through innovative medical solutions.
- Qualifications: Bachelor’s degree in life sciences or related field; 3-5 years of regulatory experience required.
- Other info: Experience with 510(k) submissions and RAC certification is a plus.
The predicted salary is between 36000 - 60000 £ per year.
We are partnered with an exciting firm who are looking to expand their regulatory function.
As a Regulatory Specialist, you will be responsible for supporting and managing regulatory submissions and registrations for medical devices across global markets. This role is ideal for someone who understands the regulatory landscape and enjoys coordinating documentation and communication with internal teams and regulatory authorities to ensure timely approvals.
Key Responsibilities:
- Prepare and submit regulatory documentation for product registrations, renewals, and amendments in accordance with global regulatory requirements (e.g., EU MDR, FDA 510(k), Health Canada, TGA, etc.).
- Maintain up-to-date knowledge of international medical device regulations and standards relevant to product registration.
- Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing, etc.) to collect, compile, and verify technical documentation (e.g., technical files, IFUs, labeling, etc.).
- Track and manage the lifecycle of global registrations, including renewals, updates, and post-market requirements.
- Support communication with regulatory authorities, distributors, and third-party representatives regarding ongoing and new submissions.
- Maintain regulatory databases, records, and registration status reports to ensure transparency and audit readiness.
- Contribute to regulatory strategy discussions and risk assessments for new product development and market expansion.
Qualifications:
- Bachelor’s degree in life sciences, biomedical engineering, regulatory affairs, or related field.
- Minimum of 3–5 years of regulatory experience in the medical device industry, with hands-on experience in product registration.
- Knowledge of global regulatory frameworks (EU MDR, FDA, etc.) and technical documentation requirements.
- Strong understanding of ISO 13485, ISO 14971, and other relevant quality system and risk management standards.
- Excellent organizational, project management, and documentation skills.
- Strong written and verbal communication in English; additional language(s) a plus.
- Ability to manage multiple projects and deadlines in a fast-paced environment.
Preferred Experience:
- Experience preparing 510(k), CE Mark submissions, or other international dossiers.
- Familiarity with Notified Bodies and interactions with regulatory agencies.
- RAC certification or postgraduate regulatory training is a plus.
Regulatory Specialist employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist
✨Tip Number 1
Network with professionals in the regulatory field, especially those who have experience with medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks mentioned in the job description, such as EU MDR and FDA 510(k). This will not only enhance your knowledge but also demonstrate your commitment and expertise during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in managing regulatory submissions and how you collaborated with cross-functional teams. Highlight specific examples that showcase your organisational and project management skills.
✨Tip Number 4
Stay updated on any changes in global regulations and standards relevant to medical devices. Being knowledgeable about recent developments can give you an edge in discussions with interviewers and show your proactive approach to the role.
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 of a Regulatory Specialist. Familiarise yourself with the key regulatory frameworks mentioned in the job description, such as EU MDR and FDA 510(k). This will help you tailor your application to highlight relevant experience.
Tailor Your CV: Customise your CV to reflect your regulatory experience in the medical device industry. Emphasise your hands-on experience with product registrations and any specific knowledge of international regulations. Use keywords from the job description to ensure your CV aligns with what the company is looking for.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the regulatory landscape. Mention specific examples of your past experiences that relate to the responsibilities outlined in the job description, such as managing submissions or collaborating with cross-functional teams.
Proofread and Edit: Before submitting your application, take the time to proofread your documents. Check for any grammatical errors or typos, and ensure that your writing is clear and professional. A well-presented application reflects your attention to detail, which is crucial in regulatory roles.
How to prepare for a job interview at Arevna
✨Know Your Regulations
Make sure you have a solid understanding of the global regulatory frameworks relevant to the role, such as EU MDR and FDA 510(k). Brush up on the latest updates and be prepared to discuss how these regulations impact product registration.
✨Showcase Your Experience
Be ready to share specific examples from your past roles where you successfully managed regulatory submissions or collaborated with cross-functional teams. Highlight any hands-on experience you have with preparing technical documentation and navigating the regulatory landscape.
✨Demonstrate Organisational Skills
Since this role requires managing multiple projects and deadlines, be prepared to discuss your project management strategies. Share how you prioritise tasks and ensure timely submissions while maintaining attention to detail.
✨Communicate Effectively
Strong communication skills are essential for this position. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory topics. If you speak additional languages, mention them as they can be a valuable asset.
