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- Tasks: Conduct literature reviews and write regulatory documents for medical devices.
- Company: Join a leading regulatory consulting company with a dynamic team.
- Benefits: Enjoy mentorship, training, generous leave, and a modern office environment.
- Why this job: Make a real impact in the medical device field while growing your career.
- Qualifications: Bachelor's degree in life sciences with excellent writing skills required.
- Other info: Collaborative culture with opportunities for personal growth and networking.
The predicted salary is between 30000 - 40000 £ per year.
We are seeking UK-based applicants for a full-time position in our core team. Join a highly professional and specialised regulatory writing team with a market-leading reputation for preparation of medical device regulatory submissions for a global client base. The successful applicant will be part of a dynamic, growing and innovative regulatory consulting company. Work will include appraisal and analysis of published clinical literature and production of literature review reports for inclusion into Clinical Evaluation submissions. Other roles include contributing to the development of a wide range of technical documents, clinical investigation files, and preparation of technical file submissions under EU MDR, IVDR and FDA.
The successful applicant will be encouraged to pioneer improvements to existing processes in a supportive environment that views all ideas, whether implemented or not, as a valuable contribution. With time, you will also have the opportunity to craft your role around your interests and unique skills. A vital attribute is an open, communicative personality that thrives in a mutually supportive and innovative environment.
Key tasks- Conduct of systematic literature reviews, appraisal and analysis of published clinical data, and production of literature review reports
- Contribution towards writing of Clinical Evaluation Plans, Clinical Evaluation Reports, and other regulatory documents under supervision of a Lead Medical Writer
- Contribution towards the development and execution of regulatory strategies for a wide range of clients
- Working in a dynamic team with a focus on constant improvement and innovation
- Assisting in compiling regulatory affairs policies, changes, and developing training for any new procedures when required
- Collaborating with clients to gather necessary information, understand their requirements and address any regulatory queries
- Learning various regulatory frameworks and keeping abreast of ongoing regulatory guidance, as well as applying them in creating new products and services
- Writing articles and creating content for the company website
As a minimum, you must have a Bachelor's degree in a life science field, medical devices or a biomedical science with grade 2:1 or above. This role does not require prior regulatory experience, but it is demanding and we need an exceptional person with appropriate qualifications who wants a stimulating career in the medical device regulatory field.
Requirements- A degree in a relevant life sciences subject, medical devices, or a biomedical field with 2:1 or above
- Excellent written English with a keen eye for detail
- A team player with superb verbal communication skills
- An understanding of international regulatory affairs including MDD, MDR, IVDR & FDA
- Ability to grasp new concepts quickly and to understand/evaluate scientific data
- Ability to work efficiently under strict deadlines
- Can work independently and as a part of the team
- Legally allowed to work in the UK
- Proficient in using IT, including Microsoft Office
This role will be office-based working from the company HQ in Sheffield. While some home-working will be available, this role is not open to remote candidates.
Our benefits are designed to support both your work and your life outside it:- Progression routes
- Mentorship and training
- Learning opportunities
- Access to regulatory events/networking
- Modern office near Meadowhall
- Free parking
- Air-conditioned office
- Epic coffee machine
- Generous annual leave
- Discretionary bonuses
- Christmas shutdown
- Free fruit
- Team social events and activities
- Inclusive & friendly environment
- Involvement in business strategy
To apply for this position, you need to complete a short writing task and submit your response alongside your CV. We aim to respond to all submissions within 5 working days.
Regulatory Medical Writer in Sheffield employer: Mantra Systems Ltd
Contact Detail:
Mantra Systems Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Medical Writer in Sheffield
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory writing field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Show us you’re genuinely interested in our work and how you can contribute to our innovative team.
✨Tip Number 3
Practice your communication skills! Since we value an open, communicative personality, being able to articulate your thoughts clearly will set you apart during interviews.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows us you’re serious about joining our dynamic team.
We think you need these skills to ace Regulatory Medical Writer in Sheffield
Some tips for your application 🫡
Read the Job Description Carefully: Before you start writing, make sure you fully understand what we're looking for. Pay attention to the key responsibilities and qualifications mentioned in the job description. This will help you tailor your application to show how you fit the role perfectly.
Showcase Your Writing Skills: As a Regulatory Medical Writer, your writing skills are crucial. Use clear, concise language and demonstrate your attention to detail in your application. Remember, this is your chance to impress us with your ability to communicate complex information effectively.
Highlight Relevant Experience: Even if you don't have direct regulatory experience, think about any relevant projects or coursework that showcase your understanding of medical devices or scientific data. Make sure to include these in your CV and writing task to give us a well-rounded view of your background.
Follow Application Instructions: Don't forget to complete the short writing task as part of your application! This is a vital step, so make sure you follow the instructions carefully. We want to see how you approach the task, so take your time and submit your best work alongside your CV through our website.
How to prepare for a job interview at Mantra Systems Ltd
✨Know Your Regulatory Stuff
Make sure you brush up on the key regulatory frameworks like MDD, MDR, IVDR, and FDA. Familiarise yourself with the latest guidelines and be ready to discuss how they apply to medical device submissions. This shows you're not just qualified but genuinely interested in the field.
✨Show Off Your Writing Skills
Since this role involves a lot of writing, prepare to showcase your written English skills. Bring examples of your previous work or even practice writing a short piece related to clinical evaluation reports. This will help demonstrate your keen eye for detail and ability to communicate effectively.
✨Be a Team Player
Highlight your collaborative spirit during the interview. Share experiences where you've worked in a team, especially in dynamic environments. Emphasising your ability to thrive in a supportive setting will resonate well with the company's culture.
✨Prepare for the Writing Task
Don't forget about the writing task! Review the instructions carefully and plan your response. This is your chance to shine, so make sure your submission is clear, concise, and showcases your understanding of the role. A well-prepared writing task can set you apart from other candidates.