Németország állások Külföldön (egészségügy, gyógyszeripar)

• Oversee and coordinate inpatient care for patients
• Ensure clinical quality oversight and support a positive inpatient experience
• Communicate directly with local treating medical teams to obtain detailed medical updates

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

• Provide medical leadership for the Near Patient Program in Germany, ensuring effective, compassionate, and compliant service delivery.
• Serve as the primary liaison between local Near Patient staff, military medical providers, and host-nation healthcare facilities.

• Develop cutting-edge optical smart instruments and medical imaging devices, utilizing multiple optical sensing modalities with a focus on medical robotics applications
• Test concepts, core functionalities, and analyze data generated by optical sensing-based hardware and software

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

• Wartung- und Reparaturarbeiten an Hologic Produkten durchzuführen
• An Planungen von Installationen teilzunehmen
• Installation von Geräten kundenseitig durchzuführen
• Kontakt mit IT-Abteilungen der Kunden aufzunehmen und Unterstützung bei der Problembehandlung von Informationssystemen zu gewährleisten

Koordination und technische Leitung interdisziplinärer Entwicklungsteams in Bezug auf das technische Management von Entwicklungsprojekten, Projektplänen, Ressourcenplänen und die Erfüllung von Designanforderungen zur Produktoptimierung...

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

Unterstützung innerhalb der F&E-Abteilung/Einführung neuer Produkte (Neuproduktentwicklung und Innovation) und anderer geschäftskritischer und/oder umsatzfördernder Maßnahmen von der Planung bis zur Kommerzialisierung...

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

Key job responsibilities - Maintain up-to-date knowledge of legislation changes affecting workplace health and ensure compliance with Amazon's policies and local health, safety, and medical regulations - Define, monitor, and report health-related metrics to GMH Leadership to measure program...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Support of our subsidiaries, distributors, clinics and patients worldwide
• Technical support for and comprehensive knowledge of the middle ear implant (VIBRANT SOUNDBRIDGE and PMEIs) and the bone conduction solutions (BONEBRIDGE and ADHEAR)