Regulatory Affairs & Quality Assurance
Permanent
On-site / In Office
Medical Writing Lead
Global Medical Devices Client
Job id: 17082
Are you ready to take the lead in shaping clinical and regulatory documentation that supports life-changing medical innovations? I’m looking for an experienced Medical Writer to join a fast-paced R&D Clinical team committed to advancing medical technology.
Summary
In this role, you'll be the go-to expert for crafting high-quality Clinical Evaluation Reports and related documents in line with evolving EU MDR regulations. You’ll collaborate with cross-functional teams ensuring scientific integrity and compliance at every stage. This is a unique opportunity to contribute to truly meaningful work while expanding your influence across global regulatory landscapes
Everything you need to know about the role
- Lead the development and maintenance of CER strategies and clinical documentation.
- Monitor and apply changes in EU MDR and FDA regulations.
- Conduct and analyse literature reviews for regulatory and safety evaluations.
- Support clinical studies through protocol writing, data analysis, and manuscript creation.
- Support with audits and responses to Notified Bodies questions
Experience and qualities that make you a strong fit
- Proven experience as a senior/lead medical writer in the medical device industry.
- Expertise in EU MDD/MDR and clinical documentation standards. CER Writing experience is essential
- Audit experience – specifically responding to questions from Notified Bodies
- Strong analytical skills in literature review and risk/benefit evaluation.
- Familiarity with regulatory submissions, design control, and cross-functional project leadership.
What’s on offer?
- A competitive salary, commensurate with experience.
- Comprehensive benefits package, including healthcare, pension, and performance bonuses.
- Opportunities for professional growth within a fast-growing medical devices company.
This Medical Writing Lead role is one not to be missed; This is your chance to be part of an innovative team making a tangible difference in the lives of patients. If you're ready for your next challenge in Medical Writing, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.
If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we’ll be more than happy to assist.