(Senior) Research Manager - Spine & Neurosurgery

Bosch Group; München; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Bereich medizinischer Technologie sucht einen engagierten Klinischen Evaluator, der klinische Studien überwacht und regulatorische Anforderungen erfüllt. In dieser spannenden Rolle arbeiten Sie eng mit verschiedenen Abteilungen zusammen, um innovative Lösungen zu entwickeln und sicherzustellen, dass die Produkte den höchsten Standards entsprechen. Sie haben die Möglichkeit, in einem internationalen Team zu arbeiten und einen bedeutenden Einfluss auf die Patientenversorgung zu haben. Wenn Sie eine Leidenschaft für medizinische Technologien und klinische Forschung haben, freuen wir uns auf Ihre Bewerbung.

Leistungen

30 Urlaubstage

Flexibles Arbeiten

Fahrradleasing

Parkgarage

Subventionierte Kantine

Fitnessprogramm

Regelmäßige Teamevents

Umfassende Weiterbildungsmöglichkeiten

Qualifikationen

• Medizinisches Studium mit Spezialisierung in Neurochirurgie oder Neurologie.
• Erfahrung in klinischer Forschung und regulatorischen Anforderungen.

Aufgaben

• Überwachung klinischer Studien und Sicherstellung der Einhaltung regulatorischer Anforderungen.
• Management von Kooperationen mit CROs und externen klinischen Anbietern.

Kenntnisse

Klinische Forschung

Projektmanagement

Stakeholder-Management

Kommunikationsfähigkeiten

Neurochirurgie

Regulatorische Anforderungen (EU MDR, FDA)

GDPR-Konformität

Wissenschaftliches Marketing

Teamführung

Englischkenntnisse

Ausbildung

Medizinisches Studium

Jobbeschreibung

Company Description

Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values: curious, authentic, and useful.

Job Description

• Oversee clinical studies, investigations and evaluations, ensuring compliance with EU MDR, FDA and other regulatory requirements
• Manage collaborations with CROs and external clinical suppliers
• Work cross-functionally with R&D, Marketing, Sales, Product Management and Quality Management
• Serve as Clinical Evaluator for Class I to Class III medical devices
• Bridge the gap between clinical research and scientific marketing to generate impactful content
• Ensure GDPR compliance in clinical collaborations
• Initiate and manage clinical studies and investigations to support product innovation and regulatory approvals
• Build and maintain a strong clinical network in Neurosurgery
• Represent the company in communications with regulatory bodies for clinical trial approvals and regulatory submissions

Qualifications

• Medical degree, ideally with specialization or strong background in Neurosurgery, Neurology or a related field
• Experience in Clinical Research within the medical device industry
• In-depth knowledge of EU MDR, FDA regulations and Good Clinical Practice
• Hands-on experience in clinical studies, clinical evaluations and regulatory submissions for medical devices
• Strong leadership experience in cross-functional collaborations
• Ability to translate clinical research into scientific marketing content
• Experience managing clinical networks in Neurosurgery is highly desirable
• Excellent project management, stakeholder management and communication skills
• Strong understanding of GDPR and clinical data protection regulations
• Very good English skills; German is a plus

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 as well as hybrid work model within Germany
• Bike leasing via cooperation partner 'BikeLeasing'
• Parking garage and safe underground bike storage
• Award-winning subsidized company restaurant and in-house cafes
• Variety-rich fitness program in our ultra-modern 360m2 company gym
• Regular after work, team, and company events
• Comprehensive training and continuing education opportunities

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.

Contact person: Géraldine Ferrer