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.

• →

  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.

• →

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

• →

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

• →

  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.

• Strong clinical writing foundation: Hands-on experience authoring CERs, CEPs, PMCFs, or SOTAs under MDR/IVDR. Comfortable moving across device categories and therapeutic areas rather than specialising in one.

• Scientific rigour: You read clinical literature critically, appraise study quality, and can defend your conclusions with evidence, both on the page and in conversation.

• Customer orientation: You communicate complex clinical content clearly and confidently to diverse audiences, from QA managers to C-level stakeholders. You take ownership of customer relationships and follow through reliably.

• Digital affinity: You genuinely enjoy working with digital tools, and you actively seek out smarter, more efficient ways to do your work. You are comfortable being an early and intensive user of AI-assisted platforms and giving critical, constructive feedback on them.

• Entrepreneurial self-organisation: You manage your own workload, deadlines, and customer commitments with a high degree of independence. Proactive, prioritising by impact, and not needing close supervision to operate effectively.

• Intellectual curiosity and adaptability: Clinical evidence standards and regulatory expectations evolve constantly. You stay ahead by reading widely, asking questions, and updating your understanding, remaining rigorous without becoming rigid.

• Attention to detail and diligence: Clinical writing leaves no room for sloppy interpretation. You are thorough, precise, and take quality seriously in every deliverable.

• Communication skills: Excellent written and spoken English is required; German is a plus given our core European customer base.

• 3-5+ years of professional experience in clinical or medical writing for medical devices, with demonstrated competence in applying MDR/IVDR requirements across real customer or project scenarios.

• A portfolio of at least 10 clinical deliverables (CERs, PMCFs, or SOTAs) that you have personally authored or substantially led. More is better; fewer is negotiable if the depth is there.

• Experience in a clinical or regulatory consulting firm is strongly preferred; time spent inside a medical device manufacturer is an additional plus. Candidates who have seen both perspectives bring a uniquely practical and client-oriented mindset.

• Demonstrated experience working with large, complex organisations, not only SMEs. Comfortable with multi-stakeholder environments, longer decision cycles, and enterprise expectations around quality, documentation, and reliability.

• Proven ability to work across multiple device categories and therapeutic areas simultaneously, switching contexts without losing rigour.

• A track record of translating clinical expertise into structured, repeatable deliverables and documentation, not just one-off advice.

• Experience with AI-assisted or digital clinical tools is a strong advantage; genuine openness and curiosity about adopting them is essential.

• Relevant qualifications in life sciences, biomedical engineering, medicine, or a related field. A PhD is a plus but not required; demonstrable practical expertise is the priority.

🇪🇺 At this stage of our company, we can only accept applications from people who are based in Europe with either European citizenship, an active working visa or being self-employed and joining us as a full-time contractor.

We strive to remove barriers, eliminate discrimination, and ensure equal opportunity through our transparent recruitment process. We are open to all groups of people without regard to age, color, national origin, race, religion, gender, sex, sexual orientation, gender identity and/or expression, marital status or any other legally protected characteristic.