Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position
The Analyst Global Post Market Surveillance (PMS) Compliance works with the Global PMS Compliance team, 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.
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 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.
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.
- 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.
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 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.
Shift: Day
