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Regulatory Affairs Manager Freelancer(m/w/x)
Regulatory compliance for Class IIa/IIb medical devices at a firm focused on early diagnosis, maintaining ISO13485, MDR, MDSAP certifications. Experience with EU/FDA regulations and ISO quality management standards required. Flexible modern workplace.
Anforderungen
- Experience with EU or FDA regulations
- Experience with ISO quality management standards
- Experience with medical device registrations
- Experience in regulatory authority audits
- Multitasking and organizational skills
- Experience optimizing cross-jurisdictional processes
- Excellent English communication skills
- Willingness to learn
- Willingness to work in fast-paced corporations
- Knowledge of the diabetes industry
- Technical understanding of innovative software
- Experience in agile environments
Aufgaben
- Support product development activities
- Ensure continuous regulatory compliance
- Maintain lean and effective regulatory processes
- Manage class IIa and IIb medical device products
- Uphold ISO13485, MDR, and MDSAP certifications
- Expand regulatory frameworks into new product fields
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- EU Medical Device regulations
- FDA Medical Device regulations
- ISO standards
- 510k Medical Device registrations
Benefits
Sonstige Vorteile
- Healthy, equal and inclusive environment
Familienfreundlichkeit
- Family friendly career paths
Fokus auf Nachhaltigkeit
- Sustainability
Gesundheits- & Fitnessangebote
- Healthy lifestyle
Modernes Büro
- Flexible modern workplace
Weiterbildungsangebote
- Culture of learning and sharing
- Professional and personal growth opportunities
Lockere Unternehmenskultur
- Open and candid feedback
Noch nicht perfekt?
- mySugr GmbHTeilzeitFreelancenur vor OrtSeniorWien
- mySugr GmbH
Medical Device Risk Manager(m/w/x)
Vollzeit/TeilzeitFreelancenur vor OrtBerufserfahrenWien - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Vollzeit/TeilzeitFreelancenur vor OrtBerufserfahrenWien - Roche Diagnostics GmbH
Compliance Expert(m/w/x)
Teilzeitnur vor OrtBerufserfahrenWienab 60.000 / Jahr - Hoval Gesellschaft m.b.H.
Freelancer Embedded Software Engineer(m/w/x)
TeilzeitFreelancenur vor OrtBerufserfahrenZeltweg, Wien
Regulatory Affairs Manager Freelancer(m/w/x)
Regulatory compliance for Class IIa/IIb medical devices at a firm focused on early diagnosis, maintaining ISO13485, MDR, MDSAP certifications. Experience with EU/FDA regulations and ISO quality management standards required. Flexible modern workplace.
Anforderungen
- Experience with EU or FDA regulations
- Experience with ISO quality management standards
- Experience with medical device registrations
- Experience in regulatory authority audits
- Multitasking and organizational skills
- Experience optimizing cross-jurisdictional processes
- Excellent English communication skills
- Willingness to learn
- Willingness to work in fast-paced corporations
- Knowledge of the diabetes industry
- Technical understanding of innovative software
- Experience in agile environments
Aufgaben
- Support product development activities
- Ensure continuous regulatory compliance
- Maintain lean and effective regulatory processes
- Manage class IIa and IIb medical device products
- Uphold ISO13485, MDR, and MDSAP certifications
- Expand regulatory frameworks into new product fields
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- EU Medical Device regulations
- FDA Medical Device regulations
- ISO standards
- 510k Medical Device registrations
Benefits
Sonstige Vorteile
- Healthy, equal and inclusive environment
Familienfreundlichkeit
- Family friendly career paths
Fokus auf Nachhaltigkeit
- Sustainability
Gesundheits- & Fitnessangebote
- Healthy lifestyle
Modernes Büro
- Flexible modern workplace
Weiterbildungsangebote
- Culture of learning and sharing
- Professional and personal growth opportunities
Lockere Unternehmenskultur
- Open and candid feedback
Über das Unternehmen
mySugr GmbH
Branche
Healthcare
Beschreibung
The company is committed to transforming healthcare through sustainable action and innovation, focusing on early diagnosis and targeted treatments.
Noch nicht perfekt?
- mySugr GmbH
Regulatory Affairs Manager Freelancer(m/w/x)
TeilzeitFreelancenur vor OrtSeniorWien - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Vollzeit/TeilzeitFreelancenur vor OrtBerufserfahrenWien - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Vollzeit/TeilzeitFreelancenur vor OrtBerufserfahrenWien - Roche Diagnostics GmbH
Compliance Expert(m/w/x)
Teilzeitnur vor OrtBerufserfahrenWienab 60.000 / Jahr - Hoval Gesellschaft m.b.H.
Freelancer Embedded Software Engineer(m/w/x)
TeilzeitFreelancenur vor OrtBerufserfahrenZeltweg, Wien