Excelya

Senior Medical Writer – Medical Devices

Excelya

contract

Posted on:

Location Type: Remote

Location: Greece

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Job Level

Senior

About the role

  • **Your Mission:**
  • - Lead the preparation and review of key medical device documentation, including **PMCF** plans/reports, **PSURs**, **CERs**, and **PMS** reports for class IIA, IIB and III medical devices.
  • - Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation.
  • - Provide expert medical and scientific input across projects, ensuring compliance with **MDR** requirements and supporting transitions **from MDD to MDR**.
  • - Respond to regulatory authority queries with clear, evidence‑based medical justifications.
  • - Collaborate with cross‑functional teams to support study‑related documentation (protocols, study reports) for **medical device projects**.
  • - 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:
  • - Degree in Life Sciences.
  • - Strong understanding of medical science, clinical practice, and the regulatory landscape for **medical devices**.
  • - Proven experience with medical writing for various classes of medical devices, including preparation of **PMCF, PSUR, CER, and PMS** documentation.
  • - Ability to interpret, evaluate, and translate complex medical research findings into clear, structured content.
  • - Experience with literature search methodologies and critical appraisal of scientific evidence.
  • - Excellent written and verbal communication skills, with the ability to convey complex information effectively.
  • - Additional experience in IVD regulatory writing is considered an asset.
  • - Fluent in English.
  • - 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’s journey. Here, you're not just doing a job, you’re becoming a key part of **something bigger**.
  • So, if you're ready to **excel with purpose**, let’s write the next chapter together.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingliterature search methodologiescritical appraisalPMCF documentationPSUR documentationCER documentationPMS documentationregulatory writingclinical practicemedical science
Soft Skills
communication skillsability to convey complex informationcollaborationcritical thinkingattention to detailorganizational skillsevidence-based justificationadaptabilityteamworkproblem-solving