Senior Regulatory Affairs Specialist

💡 As a Senior Regulatory Affairs Specialist, you are Flinn's in-house regulatory domain expert. You deliver high-quality regulatory intelligence services directly to our MedTech customers across a broad range of regulatory challenges — monitoring new regulations, identifying gaps, interpreting requirements, and supporting market expansion. This is a generalist role by design: you will work across different regulatory frameworks, across MDSAP and EU geographies, with a broad variety of device categories.

You will work inside the Product & Tech team, alongside our Product Manager — feeding your field expertise and customer observations as a knowledgeable domain partner, while the PM owns the product direction. You bring the regulatory know-how; they translate it 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 to new regulatory 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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  Continuously monitor the global regulatory landscape — new regulations, revised standards, updated guidances, and enforcement trends — across multiple geographies and device categories.

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  Evaluate and interpret complex regulatory documents (primary focus on MDSAP & EU: MDR/IVDR, FDA, PMDA, TGA, ISO standards, and associated guidances), extract applicable requirements, and deliver clear, actionable briefings to customers.

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  Proactively alert customers to changes relevant to their device portfolios before deadlines become urgent.

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  Identify gaps in customers' existing regulatory monitoring and compliance programmes, and recommend systematic ways to close them.

• Support customers seeking to expand their products into new geographic markets by mapping applicable regulatory pathways, local requirements, and submission strategies.

• Provide structured overviews of market-entry requirements across jurisdictions — from documentation to approval timelines — enabling customers to make informed go/no-go decisions.

• Act as a trusted sparring partner for customer teams navigating unfamiliar or multi-jurisdictional regulatory landscapes.

• 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 with the tools — surfacing what works, what doesn't, and what should be built next.

• Document your methodologies, decision logic, and regulatory frameworks in a systematic way so they can be reviewed, refined, and progressively automated by our product and engineering teams.

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

• Participate in customer onboarding, advisory workshops, and periodic regulatory reviews.

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

• Build trusted, long-term relationships with customer regulatory affairs teams by consistently delivering reliable, high-quality intelligence.