Director Clinical Affairs
Director Clinical Affairs
Posted on :
11-03-2025
Employer Active
1 Vacancy
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Job Description
- Lead and manage the Clinical Affairs team covering clinical evaluation/validation clinical research and scientific marketing
- Oversee clinical studies investigations and evaluations ensuring compliance with EU MDR FDA and other regulatory requirements
- Work crossfunctionally with R&D Marketing Sales Product Management and Quality Management
- Manage collaborations with CROs and external clinical suppliers
- Act as Process Owner for clinical evaluation and validation training authors and evaluators to ensure regulatory compliance
- 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
- 8 years of experience in Clinical Affairs or Clinical Research within the medical device industry
- Indepth knowledge of EU MDR FDA regulations and Good Clinical Practice
- Handson experience in clinical studies clinical evaluations and regulatory submissions for medical devices
- Strong leadership experience in with crossfunctional collaboration
- 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 mutuallysupportive 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
- Awardwinning subsidized company restaurant and inhouse cafes
- Varietyrich fitness program in our ultramodern 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: Graldine Ferrer
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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