Compliance jobs in Germany
KZA_ Head of Supply Chain - South Africa
Steinecker GmbH
Senior Manager - Clinical Affairs
Job summary
Ein etabliertes Unternehmen in der Medizintechnologie sucht einen erfahrenen klinischen Evaluator, der klinische Studien und regulatorische Anforderungen überwacht. In dieser spannenden Rolle arbeiten Sie eng mit verschiedenen Abteilungen zusammen, um sicherzustellen, dass innovative Produkte den höchsten Standards entsprechen. Sie werden die Möglichkeit haben, einen bedeutenden Einfluss auf die Entwicklung weniger invasiver Behandlungsmethoden zu nehmen und dabei in einem unterstützenden, internationalen Team zu arbeiten. Wenn Sie eine Leidenschaft für medizinische Technologien haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die ideale Gelegenheit für Sie.
Benefits
Qualifications
- Medizinische Ausbildung mit starkem Hintergrund in Neurochirurgie oder Neurologie erforderlich.
- Erfahrung in klinischer Forschung und regulatorischen Anforderungen ist entscheidend.
Responsibilities
- Überwachung klinischer Studien und Sicherstellung der Einhaltung regulatorischer Anforderungen.
- Zusammenarbeit mit CROs und externen klinischen Anbietern zur Unterstützung von Produktinnovationen.
Skills
Education
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.
- 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
- 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
- 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
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
job faster
Follow us
