Ketryx
QA/RA Lead(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Wien
ab 90.000 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
FLFlinn.ai
Senior Regulatory Affairs Specialist(m/w/x)
Wien, Berlin
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- AI-assisted platforms
- MDSAP
- EU regulations
- MDR/IVDR
- FDA
Benefits
Flexibles Arbeiten
- Flexible working hours
- Remote flexibility
Team Events & Ausflüge
- Regular team time
Attraktive Vergütung
- Employee-friendly equity packages
- Fair vesting terms
Boni & Prämien
- Profit-sharing opportunities
Modernes Büro
- Professional, high-standard environment
Fokus auf Nachhaltigkeit
- Net-zero company
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Flinn.ai erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Flinn.ai
Account Executive (DACH)(m/w/x)
Vollzeitmit HomeofficeSeniorBerlin, Wien, Frankfurt am Main - AT10 AZ Österreich GmbH
Regulatory Affairs and Medical Compliance Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 46.768,8 / Jahr - Flinn.ai
Senior Product Designer(m/w/x)
Vollzeitmit HomeofficeSeniorBerlin, Wien - Galderma Austria
Regulatory Affairs Manager Alpine(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWien
FLFlinn.ai
Senior Regulatory Affairs Specialist(m/w/x)
Wien, Berlin
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- AI-assisted platforms
- MDSAP
- EU regulations
- MDR/IVDR
- FDA
Benefits
Flexibles Arbeiten
- Flexible working hours
- Remote flexibility
Team Events & Ausflüge
- Regular team time
Attraktive Vergütung
- Employee-friendly equity packages
- Fair vesting terms
Boni & Prämien
- Profit-sharing opportunities
Modernes Büro
- Professional, high-standard environment
Fokus auf Nachhaltigkeit
- Net-zero company
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Flinn.ai erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Flinn.ai
Branche
Healthcare
Beschreibung
The company contributes directly to solutions that improve people’s health and lives by making high-quality health products accessible for everyone.
Noch nicht perfekt?
- Ketryx
QA/RA Lead(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 90.000 / Jahr - Flinn.ai
Account Executive (DACH)(m/w/x)
Vollzeitmit HomeofficeSeniorBerlin, Wien, Frankfurt am Main - AT10 AZ Österreich GmbH
Regulatory Affairs and Medical Compliance Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 46.768,8 / Jahr - Flinn.ai
Senior Product Designer(m/w/x)
Vollzeitmit HomeofficeSeniorBerlin, Wien - Galderma Austria
Regulatory Affairs Manager Alpine(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWien