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Medical Affairs Manager
hace 2 meses
Responsibilities:
* Creation and update of Clinical Evaluation Reports to ensure MDR compliance.
* Creation of the summary of safety and clinical performance (when required).
* Works closely and effectively with cross-functional teams to ensure consistency between highly linked documents: risk analysis, clinical evaluation report, PMCF plan & activities, PMS reports, and IFU.
* Identifies potential residual risks, new risks, and/or safety issues to plan, implement, and coordinate appropriate level and design of PMCF activities for our surgical portfolio.
* Interacts with third-party vendors in the creation or update of the CERs and the development of the PMCF activities (e.g., plans and reports) to support a timely and successful submission and approval by global regulatory authorities.
* Reports to global staff any risk for failure of keeping Medical Devices on the market.
Requirements:
* MD, MS, or higher degree in scientific/biological/clinical discipline.
* Minimum 5 years in Medical Affairs and/or Vigilance in the field of Surgical Medical devices.
* Clinical research expertise.
* Ideally knowledge of medical devices used in Refractive, Cataract, and Vitreoretinal surgery.
* Strong operational/strategic thinking and networking skills.
* Analytical expertise in understanding complex issues and their consequences.
* Ability to recognize potential obstacles and work to resolve them within set timelines.
* Resourceful and flexible in accepting change in priorities.
* Excellent team player with experience in cross-functional teams.
We are an equal opportunities employer and welcome applications from all qualified candidates.
Please note that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you are a motivated and experienced professional looking for a new challenge, please submit your application.
We look forward to hearing from you
