The Analyst Global Post Market Surveillance (PMS) Compliance works with the Manager Global PMS Compliance, global PMS leadership, and cross-functional 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 cross-functional business needs. This role will take responsibility for the delivery of the project deadlines and commitments.
Roles and Responsibilities:
- Support management to ensure on-going 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 cross-functional 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.
Required Knowledge, Skills, and Experience:
- Education: degree in engineering, life science, or equivalent.
- 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.
- In-depth 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 cross-functional 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
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 discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
