Regulatory Affairs Clinical Manager for Medical Device Compliance
vor 1 Woche
We are seeking an experienced Regulatory Affairs Clinical Manager to join our team at PAUL HARTMANN AG. This challenging position involves ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.
The successful candidate will have a strong understanding of regulatory requirements, MDR and relevant MDCGs, and rel. MEDDEVs. Additionally, they will possess experience in literature search and review, as well as knowledge of regulatory medical writing.
Key Responsibilities- Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance
- Cross-functional communication with other departments such as Marketing and R&D to ensure required input documentation is up to date
- Coordinate external service providers to support clinical evaluation documentation, PMCF and PMS
- Determine clinical evidence requirements according to MDR and relevant MDCGs
- Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs.
- Conduct literature searches and reviews in accordance with MDR/MEDDEV 2.7.1 rev. 4
- Provide searches in relevant vigilance databases
- Support for risk analysis and study planning for CE and PMCF studies
- University degree in life science/natural science or an equivalent qualification
- Professional experience in the medical device environment or another regulatory field of work
- Strong knowledge of regulatory requirements, MDR and relevant MDCGs, and rel. MEDDEVs
- Experience in literature search and review, as well as knowledge of regulatory medical writing
- Knowledge of database management
- Open and competent attitude when working with stakeholders
- IT affinity and proficiency with the MS Office package
- Fluent written and spoken English
- Flexible working conditions, such as flexible working hours and mobile working
- International Mobile Working
- Attractive ways of combining work and family life, e.g. childcare subsidy
- $85,000 - $110,000 per year, depending on experience and qualifications
- 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
- Company pension plan with attractive employer contribution incl. matching model for deferred compensation
- Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
- Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
- Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
- Job Bike Leasing
- Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform
-
Medical Device Compliance Specialist
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG - Karriere VollzeitJob DescriptionWe support healthcare professionals to positively impact people's lives. At HARTMANN, you have the opportunity to become part of a global team as a Manager Regulatory Affairs Clinical (f/m/d). This role offers a challenging position in an international environment where you can develop your skills and contribute to ensuring medical device...
-
Scientific Clinical Evaluation Manager
vor 1 Woche
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitCompany OverviewAt PAUL HARTMANN AG, you have the opportunity to become part of a global team. We offer a challenging position in an international environment where you can develop your skills and play an active role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety...
-
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitIn this challenging role, you will contribute to the development of our wound care portfolio as a Product Development Manager. As an interface to external service providers and internal departments, you will be an expert in wound therapy and drive innovation with passion and dedication.Responsibilities:Generate innovative ideas for new products and...
-
Electrical Engineer Product Manager
vor 2 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitProduct Development EngineerWe are looking for an experienced Electrical Engineer to join our Product Development team as a Product Manager. The successful candidate will be responsible for managing the development of new electrical products and technologies in the field of wound therapy.About the Role:Manage the development of new electrical products and...
-
Wound Care Medical Content Specialist
Vor 3 Tagen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitUnlock Career Advancement Opportunities with PAUL HARTMANN AG$140,000 - $160,000 per yearAbout UsAs a renowned leader in medical innovation, PAUL HARTMANN AG empowers professionals to shape the future of healthcare. Our mission is to provide exceptional solutions for patients and caregivers alike.About the RoleThis pivotal position involves crafting...
-
Compliance Risk Manager
vor 1 Woche
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitCompany OverviewPAUL HARTMANN AG is a leading international provider of medical and personal care products, with a strong focus on sustainability and compliance. We are seeking a highly skilled Compliance Risk Manager to join our team.
-
Compliance Management Expert for Healthcare
vor 1 Woche
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitPAUL HARTMANN AG is a leading global supplier of medical and hygiene products, seeking an experienced Compliance Management Expert. This role plays a crucial part in ensuring the company maintains its high standards of compliance. The successful candidate will have a solid background in legal and business administration with experience in compliance...
-
Senior Compliance Expert
vor 2 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG - Karriere VollzeitJob OverviewWe are seeking a highly skilled Senior Compliance Expert to join our team at PAUL HARTMANN AG. As a key member of our compliance department, you will be responsible for ensuring the development and implementation of our compliance management system.Estimated Salary: €80,000 - €110,000 per annumKey Responsibilities:Compliance System Validation...
-
Global Product Development Lead
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland HARTMANN VollzeitOverviewHARTMANN, a leading provider of innovative healthcare solutions, is seeking a highly skilled Global Product Development Lead - Electrical Engineering Expert to join our team. As a key member of our product development team, you will be responsible for driving the development of our wound care portfolio and ensuring compliance with relevant...
-
Environmental Sustainability Manager
vor 3 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Description:We are seeking an Environmental Sustainability Manager to join our team at PAUL HARTMANN AG. As a key member of our organization, you will be responsible for leading our environmental sustainability efforts and ensuring compliance with regulatory requirements.About the Role:This is a unique opportunity to make a significant impact on our...
-
Regulatory Compliance Specialist
vor 2 Wochen
Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united VollzeitYour career is no coincidence, but a strategic move to the pharmaceutical industry. Benefit from our expertise and network: GULP - experts united is currently looking for a Regulatory Compliance Specialist in the area of biopharmaceutical production.Company OverviewWe value equal opportunities and welcome applications from people with disabilities, whose...
-
Wound Expertise Specialist
vor 1 Woche
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitAs a Medical Expert as Senior Manager Wound Expertise at PAUL HARTMANN AG, you will play a pivotal role in shaping the future of healthcare through key opinion leader development and management.About UsWe are a leading medical solutions provider committed to delivering high-quality products and services that improve patient outcomes. Our team is passionate...
-
Biberach an der Riß, Baden-Württemberg, Deutschland engineering people GmbH VollzeitÜberblickSicherstellen Sie ein GMP-konformes und regulatorisches Änderungsmanagement in unserem biopharmazeutischen Bereich. Wir suchen nach einem erfahrenen Regulatory Compliance Experten, der unsere Betriebscompliance unterstützt und einen einheitlichen GMP-Compliance-Status gewährleistet.GehaltDas Gehalt für diesen Posten beträgt mindestens €...
-
Safety and Sustainability Expert
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitKey ResponsibilitiesWe are seeking an expert in Health, Safety, and Environmental (HSE) matters to provide guidance on audits, compliance monitoring, and environmental management systems.As part of our team, you will be responsible for developing, implementing, and maintaining environmental management systems to ensure regulatory compliance and continuous...
-
Netzwerk-Strategie-Manager
vor 1 Woche
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitWir suchen für unsere Division Risk Prevention einen Netzwerk-Strategie-Manager, der als Teil des Controlling Teams verantwortlich ist für die Konzeption und Umsetzung marktorientierter Produktpreisstrategien. In dieser spannenden und verantwortungsvollen Aufgabe arbeiten Sie eng mit der Business Divison Risk Prevention und den Ländern...
-
Leiterin des Clinical Project Management Teams
vor 4 Wochen
Biberach an der Riß, Baden-Württemberg, Deutschland engineering people GmbH VollzeitWir suchen eine erfahrene Leiterin für unser Clinical Project Management Team bei engineering people GmbH, einem renommierten Unternehmen im Bereich Life Science.Sicherstellen Sie den Erfolg unserer klinischen ProjekteAls Leiterin des Clinical Project Management Teams sind Sie verantwortlich für die Überwachung und Ausführung unserer klinischen Studien....
-
Clinical Trials Coordinator
vor 2 Wochen
Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united VollzeitAbout UsGULP - experts united is a leading pharmaceutical company committed to delivering innovative solutions in the field of clinical trials.SalaryThe estimated salary for this position is €60,000 - €80,000 per annum, depending on experience.Job DescriptionWe are seeking an experienced Clinical Trial Administrator to join our team in Biberach. As a key...
-
Biberach an der Riß, Baden-Württemberg, Deutschland active now Norderstedt VollzeitÜber unscleo ist Ihr persönlicher Jobfinder. Bei uns dreht sich alles um Sie: Ihre Talente, Ihre Wünsche, Ihre Ziele. Wir begleiten Sie auf Ihrer Karriereleiter, ob als Einsteiger oder erfahrene Fachkraft.Lohn und BenefitsUnser Angebot an Ihnen: Monatsgehalt: ca. 60.000 - 80.000 € brutto, je nach Erfahrung und Qualifikation. Darüber hinaus bieten wir...
-
Digital Finance Transformation Manager
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland Voith Group VollzeitAbout Voith GroupWe are a global technology company with a broad portfolio of systems, products, services and digital applications.Founded in 1867, we have around 22,000 employees, sales of € 5.5 billion and locations in over 60 countries worldwide.Digital Specialist (m|w|d) - Finance / Digital Transformation Manager (m|w|d)Job ID: 74129 | Location:...
-
Strategic Manager for Global Business Development
vor 2 Monaten
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob SummaryWe are seeking a highly skilled Senior Manager Global Strategy to lead business strategy projects on corporate or divisional level, driving the transformation of HARTMANN into a best-in-class player in its future business segments.Key ResponsibilitiesAct as a sparring partner for our business divisions and regions in developing winning...