Medical Device Strategist for Microsurgery
We are seeking a highly skilled Clinical Affairs Manager to spearhead our clinical strategy for microsurgical products.
This role will involve defining and executing the global clinical study and project roadmap, leveraging expertise in medical device development and regulatory affairs to ensure product safety and efficacy.
The ideal candidate will possess strong analytical skills, effective communication abilities, and a proven track record in project management and medical writing.
Key Responsibilities:
* Develop and implement comprehensive clinical evaluation strategies for complex microsurgical projects.
* Oversee the execution of required clinical studies and projects worldwide, including international collaborations and cross-location coordination.
* Plan and manage budgets and timelines for the entire clinical strategy.
* Evaluate clinical data for product definition, registration, and marketing purposes.
* Review and approve product-specific marketing materials and publications.
* Support Clinical/Regulatory Affairs teams globally in product registration efforts.
Requirements:
* Bachelor's or Master's degree in a natural science or related field (e.g., Medicine, Medical Engineering).
* Several years of experience in Clinical Affairs or Clinical Research within the medical device industry or with contract research organizations on medical devices.
* In-depth knowledge of regulatory requirements for clinical studies and clinical evaluations for medical devices.
* Proven experience in project management and medical writing.
* Strong analytical skills and creativity, combined with excellent communication abilities and organizational talent.
* Excellent written and spoken English and German.
* Proficient in MS Office and commonly used software tools.
Benefits include: opportunities for professional growth, collaboration with experienced professionals, and contributions to innovative medical technology solutions.