At a Glance
- Tasks: Lead clinical writing and strategy for innovative medical devices in wound care.
- Company: A growing medical device organisation with a focus on collaboration and impact.
- Benefits: Flexible part-time hours, high autonomy, and strategic influence.
- Other info: Ideal for those in the London/Hertfordshire area who thrive in agile environments.
- Why this job: Make a real difference in a close-knit team while shaping clinical processes.
- Qualifications: Experience in Clinical Affairs or RA/Clinical roles with proven CER authorship.
The predicted salary is between 30000 - 40000 £ per year.
A small and growing medical device organisation specialising in wound care is seeking an experienced Regulatory & Clinical Writer on a part-time contract basis. This is a pivotal role where you will act as the organisation’s go-to expert across Clinical/Regulatory writing, taking full ownership of the function while shaping strategy and implementing scalable processes.
This opportunity is ideal for a contractor who enjoys working in agile environments, where autonomy, visibility, and real influence are part of the day-to-day.
- Lead clinical sections of Technical Files (EU MDR Annex II & XIV)
- Author and maintain Clinical Evaluation Reports (CERs)
- Conduct literature reviews, clinical appraisal, and gap analysis
- Define clinical evidence and PMCF strategy
- Ensure alignment between clinical data, risk, and product claims
- Support Notified Body interactions and audit readiness
Requirements:
- Strong experience in Clinical Affairs or RA/Clinical roles
- Proven CER authorship under EU MDR
- Deep understanding of clinical evidence in Technical Documentation
- Experience in SME or fast-paced environments
- Excellent writing and stakeholder skills
What’s on Offer:
- Flexible part-time contract (2–3 days per week) over a 12-month period
- High level of autonomy and strategic influence
- A chance to make tangible impact within a growing, close-knit organisation
The ideal person will be based around the London/Hertfordshire area and be able to travel to the site to collaborate with the team.
Regulatory & Clinical Writer in Watford employer: Cpl Life Sciences
Join a dynamic and growing medical device organisation in Hertfordshire, where you will have the opportunity to make a significant impact as a Regulatory & Clinical Writer. With a flexible part-time contract, you will enjoy a high level of autonomy and strategic influence within a close-knit team that values collaboration and innovation. This role not only offers the chance to shape clinical strategies but also provides a supportive work culture that fosters professional growth and development.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory & Clinical Writer in Watford
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device field, especially those who have experience in regulatory and clinical writing. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Showcase your expertise! Create a portfolio that highlights your best work in Clinical Evaluation Reports and Technical Files. This will give potential employers a clear view of what you can bring to the table.
✨Tip Number 3
Prepare for interviews by brushing up on the latest EU MDR regulations and trends in clinical affairs. Being well-versed in these topics will not only impress interviewers but also show your commitment to the role.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got a range of opportunities that might just be perfect for you. Plus, it’s a great way to ensure your application gets the attention it deserves.
We think you need these skills to ace Regulatory & Clinical Writer in Watford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in Clinical Affairs and Regulatory writing. We want to see how your skills align with the specific requirements of the role, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this part-time role. We love seeing enthusiasm and a clear understanding of our needs, so let your personality come through while keeping it professional.
Showcase Your Writing Skills:As a Regulatory & Clinical Writer, your writing skills are crucial. Include samples of your previous work or mention specific documents you've authored, like Clinical Evaluation Reports. This will give us a taste of your expertise and style!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re proactive and keen to join our team!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Stuff
Make sure you brush up on your knowledge of EU MDR and the specifics of Clinical Evaluation Reports (CERs). Being able to discuss your previous experience with these documents will show that you're not just familiar, but an expert in the field.
✨Showcase Your Autonomy
Since this role requires a high level of autonomy, be prepared to share examples of how you've successfully managed projects independently. Highlight situations where you took the lead and made strategic decisions that positively impacted your previous organisation.
✨Prepare for Stakeholder Questions
Expect questions about how you handle stakeholder interactions. Think of specific instances where you effectively communicated complex clinical data to non-experts, as this will demonstrate your excellent writing and interpersonal skills.
✨Emphasise Your Agile Experience
This role is in a fast-paced environment, so be ready to discuss your experience working in agile settings. Share examples of how you've adapted quickly to changes and contributed to a collaborative team atmosphere, which is crucial for success in this position.
