Manager, Medical Affairs

Bausch & Lomb

Madrid, Spain

The Medical Affairs Manager provides support to the Clinical Evaluation Group for ongoingly assess the safety and performance clinical data of the Bausch+Lomb Surgical Medical Devices Portfolio.

He or she supports Post-Market Clinical Follow-up activities to answer MDR requirements. The Medical Manager reports directly to the Director, Surgical Global Medical Devices/Clinical Evaluation Group.

MAJOR AREAS OF RESPONSIBILITY

Creation and Update 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.

EDUCATION/COMPETENCY REQUIREMENTS

Education: 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.