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Regulatory affairs specialist • hochstadt an der aisch

Zuletzt aktualisiert: vor 10 Tagen
Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise

Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise

D105 WaveLight GmbH CompanyErlangen, Germany
Vollzeit
At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress, and act with speed as the global leader in eye care.Here, you’ll be recogn...Mehr anzeigenZuletzt aktualisiert: vor 17 Tagen
Specialist Pricing

Specialist Pricing

BNP ParibasBavière
Bavière Postulez maintenant $( document ).DAB BNP Paribas ist die Bank für unabhängige Vermögensverwalter, Fondsvermittler, Anlageberater und institutionelle Kunden. Damit sind wir in diesem Segment...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
(Senior) Manager, Medical Science Liaison, Therapy Development, Transcatheter Mitral and Tricuspid Therapies (Germany)

(Senior) Manager, Medical Science Liaison, Therapy Development, Transcatheter Mitral and Tricuspid Therapies (Germany)

Edwards LifesciencesGermany, Bayern, Remote
Homeoffice
Vollzeit
Innovation starts from the heart.At Edwards, we put patients first.We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical inn...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
German Junior Campaign Specialist – Google Ads

German Junior Campaign Specialist – Google Ads

KAMErlangen, Bavaria
Quick Apply
Teleperformance Spain, with more than 4,700 employees in 10 sites (certified with Great Place to Work and Top Employer), is looking for a creative, data-driven campaign specialist.In this role, you...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Sales Support Specialist (m / w / d)

Sales Support Specialist (m / w / d)

Stellenpakete.deMünchen, Region München, Bayern; Regierungsbezirk Oberbayern;Bayern, Germany
Sicherstellung einer hohenKundenzufriedenheit.Koordination undvergaberechtlich einwandfreie Bearbeitung von Ausschreibungen. Technischer Support in Zusammenarbeit mit demSales Specialist im Bereich ...Mehr anzeigenZuletzt aktualisiert: vor 10 Tagen
Security Specialist • (Kubernetes, Cloud)

Security Specialist • (Kubernetes, Cloud)

inovex GmbHerlangen, DE
Start : ab sofort oder zu einem späteren Zeitpunkt.Standorte : Karlsruhe, Köln, München, Hamburg, Stuttgart, Pforzheim, Erlangen oder Berlin. Im Team IT Engineering & Operations entwerfen und implemen...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Payroll Specialist (m / w / d)

Payroll Specialist (m / w / d)

DIS AGGremsdorf, Bayern, Deutschland
Bei einem unserer namhaften Kunden im Raum.Unser Kunde, ein mittelständisches Unternehmen aus dem produzierenden Gewerbe, hat in der Vergangenheit bereits international sagenhafte Erfolge verzeichn...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
German Marketing Optimisation Specialist in Lisbon

German Marketing Optimisation Specialist in Lisbon

Cross Border TalentsBavaria, Bavaria, Germany
Are you passionate about languages fluent in German and ready to dive into the dynamic marketing world.If so this is your chance to embark on an exciting journey with us in the enchanting city of.W...Mehr anzeigenZuletzt aktualisiert: vor 20 Tagen
  • Gesponsert
Personalized Internet Ads Assesor (DE) Remote

Personalized Internet Ads Assesor (DE) Remote

TELUS InternationalErlangen, Erlangen
Quick Apply
Seeking a freelance project that will allow you to work from home while making a difference in the world of.If you are someone who is passionate and enjoys staying ahead of the tech curve this.A Da...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Specialist Procurement (m / w / d)

Specialist Procurement (m / w / d)

Lorenz PersonalGremsdorf
55,00 € stündlich
Das erwartet Sie bei unserem Mandanten, einem globalen Vorreiter im Bereich Schlaftechnologie und Versorgung von Patienten mit ventilatorischer Insuffizienz : . Direktvermittlung, befristet bis 04 / 202...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Specialist Procurement (m / w / d)

Specialist Procurement (m / w / d)

ResMedGremsdorf, Germany
55,00 € stündlich
Vollzeit
Leben von Millionen Menschen und wir sind weltweit führend im Bereich Connected Care.Wir wollen gemeinsam die Lebensqualität im Bereich Schlaf und Beatmung verbessern, das Leben von Menschen mit ch...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Remote Field Service Engineering Specialist

Remote Field Service Engineering Specialist

FlowserveBavaria, Germany
Homeoffice
Vollzeit
The Field Service Engineering Specialist (for Electric Actuation & Digital Products) is a customer facing extension of the Flowserve digital products and automation engineering team.This engineer w...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Regulatory Affairs Manager (f / m / d)

Senior Regulatory Affairs Manager (f / m / d)

Siemens Healthineers AGErlangen, Baviera, Alemania
Teilzeit
Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneerin...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Mechanical Engineer Required in Munich, Germany New

Mechanical Engineer Required in Munich, Germany New

Skills ProvisionBayern, Germany
Skills Provision is searching for a Mechanical Engineer to work for a medical device manufacturing company in Germany.The Mechanical Engineer will be responsible for the design of various robot com...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Principal Cybersecurity Officer (f / m / d) - Finance - Inklusiver Job 🦼 🦻 🦯

Principal Cybersecurity Officer (f / m / d) - Finance - Inklusiver Job 🦼 🦻 🦯

Siemens EnergyErlangen, Bayern, DE
Your day begins by driving cybersecurity resilience across Digital Finance and Regulatory Requirements within Siemens Energy's corporate function. You'll collaborate with various teams to ensure tha...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Wissenschaftlicher Mitarbeiter (m / w / d) Regulatory Affairs

Wissenschaftlicher Mitarbeiter (m / w / d) Regulatory Affairs

PhytoLab GmbH & Co. KGVestenbergsgreuth, Deutschland
Erforsche die vielfältige Pflanzenwelt.Wir bei PhytoLab überzeugen seit fast 30 Jahren mit Expertise im Bereich.Pflanzenanalytik und Regulatorik. Mit modernstem Equipment sichern wir die Q...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Internal Controls Specialist Europe

Internal Controls Specialist Europe

JELD-WENSolihull, GB, B91 2AA SE Emsdetten, DE, 48282 Brilon, DE, 59929 Erlangen, DE, 91058
Internal Controls Specialist Europe.Solihull, GB, B91 2AA SE Emsdetten, DE, 48282 Brilon, DE, 59929 Erlangen, DE, 91058.Are you an Internal Controls Specialist that loves to mitigate business risks...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Treasury Specialist (m / w / d)

Treasury Specialist (m / w / d)

ISG International Service GroupBavaria
Treasury Specialist (m / w / d) Vollzeit | Rosenheim APPLYUnser Kunde entwickelt und produziert vorgedämmte Rohrsysteme für die Nah- und Fernwärmeversorgung und trägt somit einen wertvollen Teil zur En...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Logistic Specialist (m / f / d)

Logistic Specialist (m / f / d)

FluenceErlangen, Germany
100,00 € stündlich
Fluence (Nasdaq : FLNC) is a global market leader delivering intelligent energy storage and optimization software for renewables and storage. Our solutions and operational services are helping to cre...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise

Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise

D105 WaveLight GmbH CompanyErlangen, Germany
Vor 17 Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

WaveLight GmbH is a global leader in developing and producing innovative laser systems for use in eye surgery, as well as surgical planning and image guidance for cataract surgeries. Since 2009, WaveLight has been a wholly-owned subsidiary of Alcon, enabling gentle and highly precise correction of vision impairment.

We are looking for a talented and strategic Regulatory Affairs Manager (m / w / d) to join our Global Regulatory Affairs - Global Instrumentation Team in Erlangen or Berlin-Teltow. In this high-impact role, you’ll be at the forefront of navigating global regulations for ophthalmic refractive surgery equipment, diagnostic devices, and software solutions. This is your opportunity to lead the charge in achieving market success for groundbreaking technologies, while contributing to life-changing innovations.

In this role, a typical day will include :

  • Develop and implement global regulatory strategies for the approval and lifecycle management of medical devices, with a focus on the WaveLight portfolio
  • Manage global registration processes by coordinating, preparing, and reviewing submissions to ensure compliance with international regulations
  • Create and maintain technical documentation and global dossiers to maintain device registrations and support lifecycle projects
  • Strategically collaborate and negotiate with regulatory authorities, acting as the liaison between project teams and health agencies
  • Optimize product labeling and Instructions for Use (IFU) to ensure market access and compliance, while addressing country-specific submission queries
  • Lead the review and approval processes for regulatory changes, supporting external audits and regulatory inspections to ensure global compliance

WHAT YOU’LL BRING TO ALCON :

  • Degree in a related field and a proven track record of 7+ years in the medical device industry
  • Comprehensive knowledge of European, US, and Canadian medical device regulations
  • Fluency in English and German (both written and verbal)
  • Strong analytical skills, attention to detail, and expertise in MS Office tools
  • Excellent communication and negotiation skills to foster effective relationships with global authorities and cross-functional teams
  • NICE TO HAVE :

  • Familiarity with Asia-Pacific and / or Latin American medical device regulations
  • Experience with electrical / software-driven medical devices and standalone software medical devices
  • HOW YOU CAN THRIVE AT ALCON :

  • Thrive in a hybrid work environment with a competitive compensation package
  • Play a key role in the entire product lifecycle, from innovation to market success
  • Collaborate with a dedicated, high-performing team in a dynamic, supportive workplace
  • Join a global leader in medical technology, where your work contributes to life-changing advancements in eye care