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FLFlinn.ai

Senior Regulatory Affairs Specialist(m/w/x)

Wien, Berlin
Full-timeWith Home OfficeSenior
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Monitoring global MedTech regulations, standards, and enforcement trends for market expansion. MDSAP and EU MDR/IVDR interpretation experience required. Employee-friendly equity packages, remote flexibility.

Requirements

  • Solid regulatory expertise in MedTech
  • Experience interpreting and applying MDSAP & EU regulations
  • Comfortable with different regulatory systems and device categories
  • Customer orientation
  • Clear communication of technical regulatory content
  • Ownership of customer relationships
  • Digital affinity
  • Enjoyment of working with digital tools
  • Seeking efficient work methods
  • Comfortable as early user of AI-assisted platforms
  • Providing feedback on AI-assisted platforms
  • Entrepreneurial self-organisation
  • Independent workload and deadline management
  • Proactive prioritization by impact
  • Operating effectively without close supervision
  • Intellectual curiosity and adaptability
  • Staying ahead of regulatory landscape evolution
  • Rigorous but not rigid approach
  • Attention to detail and diligence
  • Thoroughness and precision in interpretation
  • Taking quality seriously in deliverables
  • Excellent written and spoken English
  • German language skills (strong plus)
  • 7+ years professional experience in medical device regulatory affairs
  • Competence in evaluating and applying MDR/IVDR or FDA requirements
  • Experience in a regulatory consulting firm (strongly preferred)
  • Experience within a medical device manufacturer (additional plus)
  • Experience working with large, complex organisations
  • Comfortable with multi-stakeholder environments
  • Understanding of enterprise expectations around quality, documentation, and reliability
  • Ability to work across multiple regulatory jurisdictions simultaneously
  • Ability to switch regulatory contexts without losing rigour
  • Translating regulatory expertise into structured, repeatable deliverables
  • Creating structured, repeatable documentation
  • Experience with AI-assisted or digital regulatory tools (strong advantage)
  • Openness and curiosity about adopting AI-assisted or digital regulatory tools (essential)
  • Relevant qualifications in life sciences, biomedical engineering, or regulatory affairs (plus)
  • Demonstrable practical expertise (priority)
  • Based in Europe
  • European citizenship, active working visa, or self-employed contractor status

Tasks

  • Monitor global regulatory landscape for new regulations
  • Monitor revised standards and updated guidances
  • Monitor enforcement trends across geographies
  • Evaluate complex regulatory documents
  • Interpret MDSAP, EU MDR/IVDR, FDA, PMDA, TGA requirements
  • Interpret ISO standards and guidances
  • Extract applicable regulatory requirements
  • Deliver clear, actionable briefings to customers
  • Alert customers to relevant changes before deadlines
  • Identify gaps in customer compliance programs
  • Recommend ways to close compliance gaps
  • Support market expansion by mapping regulatory pathways
  • Map local requirements for new markets
  • Map submission strategies for new markets
  • Provide overviews of market-entry requirements
  • Detail documentation for market entry
  • Detail approval timelines for market entry
  • Act as a sparring partner for customer teams
  • Use Flinn's AI-powered tools
  • Share feedback with the Product Manager
  • Document methodologies and decision logic
  • Document regulatory frameworks
  • Contribute to internal knowledge bases
  • Contribute to regulatory taxonomies
  • Contribute to content structures for AI
  • Participate in customer onboarding
  • Participate in advisory workshops
  • Participate in periodic regulatory reviews
  • Support Sales with domain expertise
  • Support Customer Success with domain expertise
  • Build long-term relationships with customer teams
  • Deliver reliable, high-quality intelligence

Work Experience

  • 7 years

Education

  • Bachelor's degree

Languages

  • English – Native
  • German – Business Fluent

Tools & Technologies

  • AI-assisted platforms
  • MDSAP
  • EU regulations
  • MDR/IVDR
  • FDA

Benefits

Flexible Working

  • Flexible working hours
  • Remote flexibility

Team Events

  • Regular team time

Competitive Pay

  • Employee-friendly equity packages
  • Fair vesting terms

Bonuses & Incentives

  • Profit-sharing opportunities

Modern Office

  • Professional, high-standard environment

Sustainability Focus

  • Net-zero company
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Flinn.ai and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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