Regulatory Affairs Specialist

vor 3 Monaten

Erlangen, Deutschland I. K. Hofmann GmbH Vollzeit

Regulatory Affairs Specialist (m/w/d)

Verschiedene Auszeichnungen und Zertifikate von namhaften Institutionen, dazu gehören zum Beispiel Great Place to Work, Audit Beruf und Familie, sowie der Deutsche Qualitätspreis, belegen unsere Arbeitsplatz
- und Dienstleistungsqualität

Für das Team "Regulatory Affairs" sucht unser mittelständischer Kunde der Medizintechnikbranche aus Erlagen zum nächstmöglichen Zeitpunkt einen Senior RA Specialist.

**Ihre Aufgaben**:

- Einführung von Prozessen um der Einhaltung aller Vorschriften zu entsprechen und die regulatorischen Berichtspflichten zu erfüllen
- Erstellung und Bearbeitung von Zulassungsanträge für Geräte gemäß der regulatorischen Anforderungen von US-amerikanischer FDA und der EU (MDD/MDR)
- Stetige Überprüfung und Optimierung aller Kontrollprozesse
- Enge Zusammenarbeit mit der Geschäftsleitung
- Mitarbeit an mehreren Projekten gleichzeitig
- Genereller Ansprechpartner für alle Anfragen im Bezug auf "Regulatory Excellence"
- Betreuung der bereits etablierten Produkte
- Erstellung einer optimierten regulatorischen Strategie zum Erreichen der Geschäftsziele

**Ihre Qualifikation**:

- Abgeschlossenes Studium oder mehrjährige direkte Berufserfahrung
- Sehr gute Kommunikation in Wort und Schrift auf Englisch
- Mehrjährige Berufserfahrung
- Organisations
- und Zeitmanagementtalent bei der fristgerechten Bearbeitung mehrerer parallel laufender Projekte
- Fachkenntnisse zur Beurteilung von vorhandenen Richtlinien, Prozessen und Dokumentationen unter Berücksichtigung von gesetzlichen Vorschriften

**Ihr Vorteil**:
Wir sind eine internationale Unternehmensgruppe mit über 20.000 Mitarbeitern in Deutschland, Österreich, England, der Tschechischen Republik und den USA.
- Anstellung in einem unbefristeten Arbeitsverhältnis
- Schneller und unkomplizierter Einstieg
- Qualifikationsübergreifende Einstiegsmöglichkeiten
- Übertarifliche Bezahlung
- Urlaubs
- und Weihnachtsgeld
- Langfristige und wohnortnahe Arbeitsplätze
- Chance auf Übernahme durch unsere Kunden

Bei uns finden Sie persönliche Entwicklungsmöglichkeiten durch Weiterbildung und verschiedene Einsätze bei renommierten Unternehmen aus Industrie, Handel und Dienstleistung. Bauen Sie bei und mit uns Ihr Knowhow weiter aus - wir begleiten Sie mit einer individuellen Beratung

**Ihr Kontakt zu Hofmann**:

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will be responsible for providing expert guidance and support to our manufacturing units and countries on international regulatory requirements.Key ResponsibilitiesProvide...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will be responsible for providing expert guidance and support to our manufacturing units and countries on international regulatory requirements.Key ResponsibilitiesProvide...

  • Senior Regulatory Affairs Manager

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Senior Regulatory Affairs ManagerAre you passionate about shaping the future of healthcare? We're looking for a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG.About the RoleWe're seeking a seasoned professional with a strong background in regulatory affairs for in-vivo and in-vitro medical devices. As a Senior...

  • Senior Regulatory Affairs Manager

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Senior Regulatory Affairs ManagerAre you passionate about shaping the future of healthcare? We're looking for a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG.About the RoleWe're seeking a seasoned professional with a strong background in regulatory affairs for in-vivo and in-vitro medical devices. As a Senior...

  • Regulatory Affairs Lead

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will be responsible for ensuring compliance with international regulatory requirements for in-vivo and in-vitro medical devices.Key ResponsibilitiesProvide active support to...

  • Regulatory Affairs Lead

    vor 3 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will be responsible for ensuring compliance with international regulatory requirements for in-vivo and in-vitro medical devices.Key ResponsibilitiesProvide active support to...

  • Senior Regulatory Affairs Manager

    vor 3 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Siemens Healthineers AG. As a key member of our global regulatory team, you will play a critical role in ensuring compliance with international laws, regulations, and guidelines for in-vivo medical devices and in-vitro diagnostic products.Key...

  • Senior Regulatory Affairs Manager

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Siemens Healthineers AG. As a key member of our global regulatory team, you will play a critical role in ensuring compliance with international laws, regulations, and guidelines for in-vivo medical devices and in-vitro diagnostic products.Key...

  • Senior Regulatory Affairs Manager

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will play a critical role in ensuring compliance with international regulatory requirements for in-vivo and in-vitro medical devices.Key ResponsibilitiesProvide active support...

  • Senior Regulatory Affairs Manager

    vor 3 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will play a critical role in ensuring compliance with international regulatory requirements for in-vivo and in-vitro medical devices.Key ResponsibilitiesProvide active support...

  • Regulatory Affairs Director

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About Siemens Healthineers AGWe are a leading global medical technology company dedicated to shaping the future of healthcare. Our innovative technologies and services improve the lives of millions of patients worldwide.Our CultureWe value diversity, open debate, and a willingness to challenge conventional thinking. Our dynamic environment encourages growth,...

  • Regulatory Affairs Director

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About Siemens Healthineers AGWe are a leading global medical technology company dedicated to shaping the future of healthcare. Our innovative technologies and services improve the lives of millions of patients worldwide.Our CultureWe value diversity, open debate, and a willingness to challenge conventional thinking. Our dynamic environment encourages growth,...

  • Senior Regulatory Affairs Manager

    vor 3 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will play a critical role in ensuring compliance with international regulatory requirements for in-vivo medical devices and in-vitro diagnostic products.Key...

  • Senior Regulatory Affairs Manager

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will play a critical role in ensuring compliance with international regulatory requirements for in-vivo medical devices and in-vitro diagnostic products.Key...

  • Lead Manager of Regulatory Affairs

    vor 1 Monat

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Are you ready to contribute to the advancement of healthcare? At Siemens Healthineers, we honor our dedicated professionals who bring energy and passion to this vital field. Our legacy of engineering excellence in the healthcare sector drives us forward.We provide a flexible and dynamic workplace that encourages personal and professional growth. Interested...

  • Lead Manager of Regulatory Affairs

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Are you ready to contribute to the advancement of healthcare? At Siemens Healthineers, we honor our dedicated professionals who bring energy and passion to this vital field. Our legacy of engineering excellence in the healthcare sector drives us forward.We provide a flexible and dynamic workplace that encourages personal and professional growth. Interested...

  • Lead Manager of Regulatory Affairs

    vor 1 Monat

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Are you ready to contribute to the advancement of healthcare? At Siemens Healthineers, we are committed to innovation and excellence in the medical technology sector. Our mission is driven by the dedication and expertise of our team members who are passionate about making a difference in the industry.We provide a flexible and stimulating work environment...

  • Lead Manager of Regulatory Affairs

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Are you ready to contribute to the advancement of healthcare? At Siemens Healthineers, we are committed to innovation and excellence in the medical technology sector. Our mission is driven by the dedication and expertise of our team members who are passionate about making a difference in the industry.We provide a flexible and stimulating work environment...

  • Senior Regulatory Affairs Director

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    **About Us**Siemens Healthineers AG is a leading global medical technology company that is shaping the future of healthcare. Our company is driven by a team of 71,000 dedicated colleagues in over 75 countries who are passionate about creating innovative technologies and services that improve patient outcomes.**Our Culture**We value diversity, open debate,...

  • Senior Regulatory Affairs Director

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    **About Us**Siemens Healthineers AG is a leading global medical technology company that is shaping the future of healthcare. Our company is driven by a team of 71,000 dedicated colleagues in over 75 countries who are passionate about creating innovative technologies and services that improve patient outcomes.**Our Culture**We value diversity, open debate,...