Medical Affairs Manager
hace 2 días
Bausch & Lomb is seeking a highly skilled Medical Affairs Manager to provide support to the Clinical Evaluation Group for ongoing assessment of the safety and performance clinical data of the Bausch+Lomb Surgical Medical Devices Portfolio.
Key Responsibilities- Clinical Evaluation Reports: Create and update Clinical Evaluation Reports to ensure compliance with regulatory requirements.
- Summary of Safety and Clinical Performance: Develop a summary of safety and clinical performance for the Surgical Medical Devices Portfolio.
- Cross-Functional Collaboration: Work closely with cross-functional teams to ensure consistency between highly linked documents, including risk analysis, clinical evaluation reports, post-market clinical follow-up plans and activities, performance monitoring reports, and instructions for use.
- Risk Identification and Mitigation: Identify potential residual risks, new risks, and/or safety issues to plan, implement, and coordinate appropriate level and design of post-market clinical follow-up activities for the Surgical Medical Devices Portfolio.
- Vendor Collaboration: Interact with third-party vendors in the creation or update of Clinical Evaluation Reports and the development of post-market clinical follow-up activities to support timely and successful submission and approval by global regulatory authorities.
- Risk Reporting: Report to global staff any risk for failure of keeping Medical Devices on the market.
Internal: Global Clinical Evaluation Group, Clinical and Medical Affairs teams, Regulatory Affairs, Clinical services, Legal Manufacturer Quality teams, Post Market Surveillance teams, International Marketing Departments.
RequirementsEducation: MD, MS, or higher degree in scientific/biological/clinical discipline.
Experience: 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.
Competencies: Strong operational/strategic thinking and networking skills, analytical expertise in understanding complex issues and the consequences, abilities 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, excellent communication skills.
Bausch & Lomb is an equal opportunity employer and welcomes applications from diverse candidates.
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