Senior Medical Writer

Are you passionate about transforming complex clinical and scientific data into high-quality regulatory documentation that supports innovative medical devices reaching patients worldwide?

ProPharma is seeking an experienced Senior Medical Writer I to join our growing Medical Writing team. In this role, you will lead the development of global regulatory and clinical documentation for medical devices and diagnostics, collaborating with cross-functional experts and international clients in a dynamic, science-driven environment.

What You'll Do

• Author and review high-quality Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF documentation, Safety & Performance Summaries, regulatory submissions, and other medical device regulatory documents.
• Support global submissions and compliance activities under EU MDR/IVDR and other international regulatory frameworks.
• Analyze and present clinical, scientific, and regulatory data in a clear, concise, and compliant manner.
• Collaborate with Regulatory Affairs, Clinical Affairs, Biostatistics, Medical Safety, and Subject Matter Experts to develop submission-ready documentation.
• Lead client discussions, manage timelines, and ensure successful delivery of complex writing projects.
• Mentor junior writers and contribute to continuous process improvement initiatives.
• Stay current on evolving global medical device regulations, guidance documents, and industry best practices.

What We're Looking For

• 4+ years of medical writing experience, with significant exposure to medical device and/or diagnostics regulatory documentation.
• Strong experience authoring CERs, CEPs, PMCF reports, PMCF Plans, SSCPs, PSURs, or other MDR/IVDR-related documents.
• Deep understanding of EU MDR (2017/745), IVDR (2017/746), MEDDEV guidance, and global regulatory requirements.
• Ability to critically appraise scientific literature, interpret clinical data, and communicate complex findings effectively.
• Excellent project management, stakeholder engagement, and client-facing communication skills.
• Strong attention to detail, quality, and document consistency.
• Bachelor's degree or higher in a life sciences, medical, pharmacy, biomedical engineering, or related scientific discipline.

Why Join ProPharma?

• Work on diverse and innovative medical device and diagnostic technologies across multiple therapeutic areas.
• Partner with leading global manufacturers and regulatory experts.
• Gain exposure to complex international regulatory strategies and submissions.
• Enjoy a collaborative culture focused on scientific excellence, professional growth, and career advancement.
• Be part of a team dedicated to improving patient outcomes through regulatory and clinical excellence.

If you have a passion for medical device regulatory writing and expertise in CERs, MDR/IVDR compliance, and clinical evaluation, we'd love to hear from you.