You lead the Clinical Affairs team, overseeing studies and ensuring compliance while collaborating with various departments. Your role includes managing external partnerships and creating content that bridges clinical research with marketing efforts.
Anforderungen
- •Technical university degree
- •Strong leadership experience
- •Several years in Clinical Affairs
- •In-depth knowledge of EU MDR
- •Hands-on experience in clinical studies
- •Ability to translate clinical research
- •Excellent project management skills
- •Strong understanding of GDPR
- •Very good English skills
Deine Aufgaben
- •Lead and manage the Clinical Affairs team.
- •Oversee clinical studies and ensure regulatory compliance.
- •Collaborate with R&D, Marketing, Sales, and Quality Management.
- •Manage relationships with CROs and external suppliers.
- •Train authors and evaluators for regulatory compliance.
- •Serve as Clinical Evaluator for medical devices.
- •Create impactful content bridging clinical research and marketing.
- •Ensure GDPR compliance in clinical collaborations.
- •Initiate and manage clinical studies for product innovation.
- •Build a strong clinical network in Neurosurgery.
- •Communicate with regulatory bodies for trial approvals.
Deine Vorteile
Mutually-supportive international team
Meaningful work with impact
30 vacation days plus holidays
Flexible hours and hybrid model
Bike leasing program
Parking garage and bike storage
Subsidized company restaurant
Fitness program in company gym
Regular team and company events
Training and continuing education
Original Beschreibung
## 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 cross-functionally 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
* Technical university degree
* Strong leadership experience with cross-functional collaboration
* Several years of experience in Clinical Affairs, Clinical Research and/or R&D 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
* Ability to translate clinical research into scientific marketing content
* 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