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Regulatory affairs director • kamen

Zuletzt aktualisiert: vor 7 Stunden
QM Consultant - Regulatory Affairs (m / w / d)

QM Consultant - Regulatory Affairs (m / w / d)

Dr. Langer Medical GmbHDortmund, DE
Über uns Company Description Dr.Langer Medical GmbH, based in Waldkirch, Germany, which has been part of Brainlab in Munich since 2022, has specialized in the development and marketing of highly in...Mehr anzeigenZuletzt aktualisiert: vor 10 Tagen
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Medical Affairs Manager

Medical Affairs Manager

Established SearchDortmund, DE
Medical Affairs Manager – Europe.We are looking for an accomplished and driven.Medical Affairs Manager - Europe.Europe for a pioneering Class III implantable medical device.This position plays a cr...Mehr anzeigenZuletzt aktualisiert: vor 27 Tagen
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Online Data Research - German - Remote

Online Data Research - German - Remote

TELUS Digital, Dortmund
Homeoffice
Quick Apply
Looking for a freelance opportunity where you can make an impact on technology from the comfort of your home? If you are dynamic, tech-savvy, and always online to learn more, this part-time flexibl...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
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Senior Director of Technical Services

Senior Director of Technical Services

Catalyst Life SciencesNorth Rhine-Westphalia, Germany, Germany
On behalf of a client, I am seeking a Senior Director of Technical Services (m / w / d).This role offers a unique opportunity to drive technical and strategic leadership at a large, complex, and innova...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
IT-Consultant Security Regulatory (all genders)

IT-Consultant Security Regulatory (all genders)

adesso SEDortmund, Nordrhein-Westfalen, DE
Quick Apply
IT-Exzellenz und damit auch für exzellente Entwicklungsmöglichkeiten für alle adessi.Wir wachsen gemeinsam und lernen voneinander – an unseren Projekten, im Team und mit herausragenden Trainingsang...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Program Director

Program Director

Meet Life SciencesDortmund, DE
Programme Director | Digital Healthcare Engagement (Germany-Based).A leading healthcare engagement agency is seeking a.Germany-based Programme Director. This strategic role blends programme delivery...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
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Research Director

Research Director

Jellyfish RecruitmentDortmund, DE
Research Director (Life Sciences / Consumer).A well-established life sciences research consultancy is seeking a Research Director with strong quantitative & qualitative expertise to lead their expand...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
Senior Regional PSRC Manager EAME

Senior Regional PSRC Manager EAME

HuntsmanGermany, Bergkamen
Senior Regional PSRC Manager EAME.Huntsman has a rare opportunity for an experienced.This role is a pivotal leadership role at the helm of ensuring excellence in product safety and regulatory affai...Mehr anzeigenZuletzt aktualisiert: vor 18 Tagen
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Project Development Director - Renewables

Project Development Director - Renewables

Taylor Hopkinson | Powered by BrunelDortmund, DE
Opportunity for a senior level project development professional to join a leading renewable energy developer company as Project Development Director / Country Head. Remote, ideally in Munich or Frank...Mehr anzeigenZuletzt aktualisiert: vor 10 Tagen
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General Manager -DACH

General Manager -DACH

Morgan Prestwich - Life Science & Healthcare Executive SearchDortmund, DE
Job Title : General Manager – DACH Region.Germany (Flexible, with regular travel across DACH).Confidential] – US-Headquartered Rare Disease Biotech. We are a US-headquartered, innovation-driven biote...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
Referent (m / w / d) Quality & Regulatory Affairs

Referent (m / w / d) Quality & Regulatory Affairs

ecm partnersDortmund, DE
Über uns Über unsUnser Klient gehört zu den Marktführern und Innovationstreibern auf dem Gebiet der intelligenten Systemkomponenten für die Fabrikautomation und ist technologischer Partner für vers...Mehr anzeigenZuletzt aktualisiert: vor 14 Tagen
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Permitting and Regulatory Reform Specialist (CRM Projects)

Permitting and Regulatory Reform Specialist (CRM Projects)

NTU International A / SDortmund, DE
Permitting and Regulatory Reform Specialist (CRM Projects).Short-term assignments / task-based consultancy.Permitting and Regulatory Reform Specialists (CRM Projects). EC-SG REFORM / 2025 / OP / 0001 : Pro...Mehr anzeigenZuletzt aktualisiert: vor 18 Tagen
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Medical Science Liaison

Medical Science Liaison

InizioDortmund, DE
Join as an MSL DACH (gn) – Biomarker for Neurodegenerative Diseases.Our client and philosophy of this role.Beckman Coulter—part of the Danaher Group—is seeking a dynamic and experienced Medical Sci...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
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Director Supply Chain Management

Director Supply Chain Management

Skills AllianceDortmund, DE
European pharmaceutical company.EU markets and a growing pipeline of branded and generic products.With a reputation for high-quality manufacturing, regulatory compliance, and a broad therapeutic po...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
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Senior Director CMC Regulatory Affairs

Senior Director CMC Regulatory Affairs

BioTalentDortmund, DE
Our client are a clinical stage biotech company pioneering in the ADC space.They recently completed an oversubscribed financing round and innovating in the IO space. They have recently entered Phase...Mehr anzeigenZuletzt aktualisiert: vor 18 Tagen
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Director of Pathology - Germany

Director of Pathology - Germany

Hartmann YoungDortmund, DE
A globally recognised provider of biospecimen solutions and laboratory services is seeking a Director of Pathology.The organisation supports drug discovery and development through an extensive port...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Business Consultant - Regulatory, Risk and Compliance (m / w / d)

Business Consultant - Regulatory, Risk and Compliance (m / w / d)

Winfried Bungert Executive SearchDortmund, Nordrhein-Westfalen, DE
Quick Apply
Über uns Starte deine neue Herausforderung in den Bereichen Finance, Risiko, Controlling und Compliance! Aufgaben - das erwartet dich Strategische Beratung der Kunden bei der Umsetzung regulatorisc...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Referent Legal Affairs als Corporate Counsel Regulierungsrecht (m / w / d)

Referent Legal Affairs als Corporate Counsel Regulierungsrecht (m / w / d)

Westnetz GmbHDortmund, Germany
Team Regulierungsrecht / Vertragsrecht / Unbundling, Standort Dortmund,.Zeitpunkt befristet für 2 Jahre engagierte Verstärkung. Deine Arbeit sollte sinnstiftend sein und Du willst Dich mit all...Mehr anzeigenZuletzt aktualisiert: vor 7 Stunden
Global Regulatory Affairs Team LeaderNonStop Consulting

Global Regulatory Affairs Team LeaderNonStop Consulting

NonStop ConsultingNorth Rhine-Westphalia, Germany
Homeoffice
Global Regulatory Affairs Team Leader.Our client, a global leader in agricultural solutions, is seeking a highly experienced Regulatory Affairs Team Leader to join their dynamic team in North Rhine...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director, Human Resources

Director, Human Resources

Regal RexnordUnna, North Rhine, Westphalia, Germany
Reporting to the Senior HR Director for the Clutches & Brakes Division, the.Heavy Duty Operational leader of the Division and will be an important member of the Operations leadership team, contribu...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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QM Consultant - Regulatory Affairs (m / w / d)

QM Consultant - Regulatory Affairs (m / w / d)

Dr. Langer Medical GmbHDortmund, DE
Vor 10 Tagen
Stellenbeschreibung

Über uns Company Description Dr. Langer Medical GmbH, based in Waldkirch, Germany, which has been part of Brainlab in Munich since 2022, has specialized in the development and marketing of highly innovative medical technology for intraoperative neuromonitoring and neurostimulation for more than 25 years. Our products are groundbreaking in design and handling and form the basis for our worldwide growth. It is therefore no coincidence that the products from Dr. Langer Medical as well as the company itself have been honored several times in the past with various prizes and awards. Job Description You are interested in Regulatory Affairs or in the development of medical devices? As QM Consultant in our Regulatory Affairs team you will interact with Dr. Langer Medical departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Dr. Langer Medical products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects. Your duties include : - Collaboration on the creation, updating and review of the technical documentation before / after CE marking a new / changed medical device - Evaluate and follow up design changes during the development and implementation - Participation in the documentation of product changes - change management - Discuss regulatory topics with R&D colleagues and other departments - Establish global regulatory strategies for the medical devices of Dr. Langer Medical in collaboration with local partners of the Brainlab subsidiaries - Compile regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities - Monitor & investigate regulatory requirements in pre-defined countries - Participation and preparation of regulatory audits and follow up improvement opportunities - Regular market monitoring and preparation of PMS / PSU reports - Train Dr. Langer Medical employees in regulatory requirements Qualifications - Degree in (medical) engineering or life sciences preferred, but other degrees may be considered - Knowledge and experience of medical device regulations such as EN ISO 13485 and MDR (Inhalt entfernt) as well as FDA 21 CFR part 820 (QSR) and MDSAP - Professional experience in regulatory affairs or regulatory compliance in the medical device field. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D) - Excellent English and proficient German written and verbal communication skills - Ability to communicate with all stakeholders - Independent, structured and pragmatic working style - Persuasive power Additional Information - A mutually-supportive, international team - Meaningful work with a lasting impact on medical technology - 30 vacation days, plus December 24th and December 31st - Flexible working hours - Regular team, and company events - Internal company fitness program - Comprehensive training and continuing education opportunities offered by Brainlab SE - TOP 100 innovator and employer of the future 2022 Ready to apply? We look forward to receiving your online application including your first available start date and desired salary. Contact person : Géraldine Ferrer