Medical Writer (w/m/d)

💡As a Medical Writer, you are Flinn's in-house clinical documentation expert. You produce high quality clinical deliverables directly for our MedTech customers across the full MDR/IVDR lifecycle: Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF plans and reports, State of the Art (SOTA) reports, and PSURs. This is a generalist role by design: you will work across device categories, therapeutic areas, and risk classes, rather than specialising in one narrow niche.

You will work inside the Clinical team alongside our Product Managers, bringing your field expertise as a knowledgeable domain partner. Your day-to-day is rooted in clinical documentation; the PMs own the product direction and translate your rigour into software.

Over time, you will help codify your expertise into Flinn's AI-powered platform by working systematically with our tools and sharing structured feedback, so that software automation progressively increases while you help expand the solution offering into new clinical challenges.

The role is based within commuting distance of Vienna or Berlin, with regular in-office collaboration and strong remote flexibility.

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  Author Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF plans and reports, State of the Art (SOTA) reports, and PSURs across a range of device classes and therapeutic areas.

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  Conduct systematic literature reviews and structured evidence appraisal, maintaining traceability between clinical data, regulatory requirements, and device claims.

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  Integrate post-market data, complaint information, and safety signals into clinical reasoning and conclusions.

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  Produce deliverables that stand up to notified body scrutiny the first time, rather than relying on rework cycles.

• Prepare and defend clinical documentation in notified body audits and technical file reviews.

• Respond rapidly and precisely to reviewer questions; integrate feedback into revised deliverables without losing the thread of the original argument.

• Support customers through fast-turnaround submissions when timelines get tight.

• Use Flinn's internal AI-powered tools as your primary working environment, operating at maximum efficiency and continuously pushing the capabilities of what the platform can do.

• Share structured, high-quality feedback with the Product Manager based on your daily experience: what works, what doesn't, and what should be built next.

• Document your methodologies, templates, and decision logic systematically, so they can be reviewed, refined, and progressively automated by our product and engineering teams.

• Contribute to building internal knowledge bases, clinical taxonomies, and content structures that power Flinn's AI capabilities.

• Support our product development team with clinical subject-matter expertise and insights that inform the design and testing of new products.

• Participate in customer onboarding, clinical strategy workshops, and periodic clinical reviews.

• Support Sales and Customer Success with domain expertise during commercial conversations and proposals.

• Build trusted, long-term relationships with customer Clinical and Regulatory Affairs teams by consistently delivering reliable, high-quality documentation.