Regulatory affairs manager Jobs in Carmel, IN

Job Description

Job Description

Description :

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

OVERVIEW :

The CTS III is responsible for providing world class training and support for physicians and staff on the use and integration of RxSight products and technology. Position will support clinical efforts at Customer site(s) via clinical support and monitoring surgery, supporting clinical evaluations and LDD treatments, reviewing post-operative visits and patient follow-ups and supporting clinical data collection for completion and compliance with Good Clinical Practice (GCP). Position will provide consistent, high-level support to Customer sites, fostering full integration of RxSight products and device-related clinical methods into their clinical practice. Position will support commercial customer sites as well as investigational study sites in a highly regulated environment, providing timely data feedback and reporting as needed. Position will interact heavily with Customers as well as internal RxSight departments to maintain a well-developed, transparent communication path to ensure the voice of the customer is clearly and consistently heard.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Train Physicians and staff on RxSight technology and best practices.
• Communicate with sites to identify key on-site personnel, set proper expectations to ensure full site readiness to accept RxSight technology prior to customer onboarding.
• Ensure staff supporting physicians are fully educated and trained on RxSight technology to full competence, enabling Rapid Adoption of RxSight technology within the customer site.
• Oversee and manage Customer introduction, onboarding and ongoing training / educational activities to ensure full operational competence in compliance with current Standard Operating Procedures (SOPs) as directed.
• Ensure continuous procedure and training adherence for trained staff and physicians by conducting periodic audits of the effectiveness of the Clinical Training program.
• Assist with customer complaint-handling and management, as applicable.
• Support and manage Clinical Study sites to include : monitoring and maintaining compliance to clinical protocols, data integrity, data collection, documentation and transfer practices.
• Assist with On-the-Job Training (OJT) of new RxSight clinical applications personnel to ensure training effectiveness and competence to training standards.
• Provide consistent clinical support to set expectations and properly educate and train customers with regards to patient evaluation / selection, RxLAL implantation as well as postoperative evaluation and LDD treatments with a focus on patient safety, customer support and continuous improvement of the Clinical Training program.
• Provide strategies and feedback for implementing clinical methodology to optimize results of RxSight technology.
• Assist and / or lead troubleshooting efforts regarding unexpected clinically-relevant incidents; involving other members of the company for support and / or expertise as deemed appropriate.
• Monitor and update the Training Portal regularly to ensure accurate reflection of CTS / customer activity as well as training readiness of each customer site.
• Provide excellent Customer support for customers assigned within your geographical region as measured by periodic Customer Satisfaction Surveys.
• Monitor and analyze trends within your specific region and ensure communication to the Director, Global Clinical Operations, Associate Director, Global Clinical Education, RD&E and other departments as appropriate for continued process improvement.
• Attend and support global trade shows, meetings and conferences when required.
• Assist with clinical data collection, analysis and presentation as needed.

Requirements :

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES :

SUPERVISORY RESPONSIBILITIES :

EDUCATION, EXPERIENCE, and TRAINING :

CERTIFICATES, LICENSES, REGISTRATIONS :

COMPUTER SKILLS :