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.

Why Flinn?

• We are building a truly exceptional culture: While many companies claim to have a great culture, we invite you to discover what truly sets ours apart. Visit our career page, speak with our team, listen to our founders’ podcast, or experience our culture first-hand during the interview process.

• Make a Meaningful Impact: Your work at Flinn contributes directly to solutions that improve people’s health and lives by making high-quality health products accessible for everyone.

• Experienced, well-funded, highly professional: As well-funded startup veterans, we know how to sustain long-term business health and success, ensuring an environment for continuous personal growth.

What is in for you?

• Join a fast-growing, well-funded European startup backed by experienced founders and investors.

• Be part of a mission-driven health-tech company whose work directly improves people’s lives.

• Take end-to-end ownership of core operational processes that keep the company running.

• Play a key role in scaling Flinn, shaping how operations work as we grow.

• Work in a high-trust, low-ego environment with autonomy and clear ownership.

• Enjoy flexible working hours, remote flexibility, and regular team time in Vienna.

• Work in a net-zero company where all unavoidable CO₂ emissions are compensated with carefully selected, high-quality removal certificates.

• Receive one of the most employee-friendly equity packages, including fair vesting terms and profit-sharing opportunities.

• Grow in a professional, high-standard environment that supports long-term personal and career development.

Your contributions to our journey:

• Your core responsibility is to deliver expert regulatory intelligence services to Flinn's customers with precision, speed, and reliability. Concretely, you will…

  • Regulatory Monitoring & Intelligence

    • Continuously monitor the global regulatory landscape — new regulations, revised standards, updated guidances, and enforcement trends — across multiple geographies and device categories.

    • 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.

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

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

  • Market Expansion Support

    • 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.

  • Tool Usage & Knowledge Capture

    • 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.

  • Customer Engagement

    • 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.

Requirements

What you need to be successful:

• Broad regulatory expertise: Solid, hands-on experience interpreting and applying regulatory requirements across MedTech — focusing on MDSAP & EU regulations and standards. Comfortable moving across different regulatory systems and device categories rather than specialising in one.

• Customer orientation: You communicate technical regulatory 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: Regulatory landscapes evolve constantly. You stay ahead by reading widely, asking questions, and updating your understanding — remaining rigorous without becoming rigid.

• Attention to detail and diligence: Regulatory work 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 strong plus given our core European customer base.

Attributes we are looking for:

• 7+ years of professional experience in regulatory affairs for medical devices, with demonstrated competence in evaluating and applying MDR/IVDR and/or FDA requirements across real customer or project scenarios.

• Experience in a 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 regulatory jurisdictions and device categories simultaneously, switching contexts without losing rigour.

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

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

• Relevant qualifications in life sciences, biomedical engineering, regulatory affairs, or a related field are a plus, though 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.