Redefine Medical. Empower Innovation. Build with Audacity.
Join Excelya as Our Next Medical Star!
At Excelya, we don鈥檛 just work鈥攚e Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience.
Now, we鈥檙e calling on curious minds and courageous spirits to step into a career-defining role in Medical Affairs. Ready to make an impact that travels the globe? Let鈥檚 talk.
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About the Job
We are seeking a Freelancer **Senior Medical Writer, experienced with medical devices, **for a part-time fully remote role,聽to provide medical and scientific expertise required for the successful completion of Excelya鈥檚 projects.
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Your Mission:
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Lead the preparation and review of key medical device documentation, including PMCF聽plans/reports, PSURs, CERs, and PMS聽reports for class IIA, IIB and III medical devices.
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Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation.
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Provide expert medical and scientific input across projects, ensuring compliance with MDR聽requirements and supporting transitions from MDD to MDR.
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Respond to regulatory authority queries with clear, evidence鈥慴ased medical justifications.
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Collaborate with cross鈥慺unctional teams to support study鈥憆elated documentation (protocols, study reports) for medical device projects.
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Participate in scientific meetings and stay updated on clinical and regulatory developments in the medical device field.
Requirements
What You Bring to the Table:
We are looking for candidates who embody our values of Audacity, Care, and Energy and also:
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Degree in Life Sciences.
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Strong understanding of medical science, clinical practice, and the regulatory landscape for medical devices.
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Proven experience with medical writing for various classes of medical devices, including preparation of PMCF, PSUR, CER, and PMS聽documentation.
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Ability to interpret, evaluate, and translate complex medical research findings into clear, structured content.
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Experience with literature search methodologies and critical appraisal of scientific evidence.
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Excellent written and verbal communication skills, with the ability to convey complex information effectively.
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Additional experience in IVD regulatory writing聽is considered an asset.
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Fluent in English.
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Knowledge of French language is a plus.
Benefits
Why Choose Excelya?
At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient鈥檚 journey. Here, you're not just doing a job, you鈥檙e becoming a key part of something bigger.
So, if you're ready to excel with purpose, let鈥檚 write the next chapter together.