Analyst Global PMS Compliance

Primary Function of Position

The Analyst Global Post Market Surveillance (PMS) Compliance works with the Global PMS Compliance team global PMS leadership and crossfunctional teams to ensure corporate/regional alignment and regulatory compliance.

Primary responsibilities will include continuous monitoring of the global post market surveillance regulatory landscape and collaboration with global post market teams to implement proactive procedure/process/system improvements to ensure compliance.

In addition this role will perform project management for PMS projects and CAPAs relevant to global compliance ensuring the product vision priorities and solutions are actively serving functional and crossfunctional business needs. This role will take responsibility for the delivery of the project deadlines and commitments.

As the Intuitive business continues to grow and the global PMS regulatory requirements continue to increase this role will support improvement of the Intuitive PMS overall compliance effectiveness and efficiency.

Essential Job Duties

• Support management to ensure ongoing compliance of Intuitive to global PMS requirements and alignment of internal corporate/regional PMS teams.
• Continuously evaluate Intuitive PMS against any new emerging or updated global PMS regulatory requirements and proactively support implementation of procedure process system changes and training to address.
• Participate in internal/external audits as necessary; provide PMS SME expertise in the front and back room when needed.
• Author and manage global PMS regulatory responses as needed and ensure Intuitive RAQA and crossfunctional alignment.
• Lead and organize project teams to drive focused results and projects/CAPAs related to global PMS compliance.
• Accomplish project objectives by planning and evaluating project related activities and communicating status to management on a regular basis.
• Prepare and complete action plans to implement productivity quality problem resolving identifying trends determine system improvements and implement change.
• Perform other duties as directed.

Qualifications :

Required Skills and Experience

• Experience: 3 years of experience in the medical device field with specific experience in the following: project management Quality Management System activities/implementation and/or active participation in audits/inspections.
• Indepth knowledge and understanding of global medical device regulations requirements and standards such as ISO 13485 MDD EU MDR US FDA requirements local regulations/guidance documents etc.
• Ability to handle multiple tasks and to prioritize and schedule workload to meet business needs independently.
• Demonstrate good interpersonal skills ability to work with others in international team environment effective interactions in crossfunctional teams.
• Organizational and planning skills including action oriented focused urgency and driving for results.
• Orientation for work result details with emphasis on accuracy and completeness.

Required Education and Training

Undergraduate degree in engineering life science or equivalent.

Preferred Skills and Experience

• Experience and/or training: Project Management
• Experience and/or training: Audits/Inspections

Additional Information :

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.

Remote Work :

No

Employment Type :

Fulltime