Regulatory Postmarket Specialist

Company Description

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 Post-Market Surveillance Report Specialist provides expertise and support for the development of post-market strategies, plans and reports for new and existing Intuitive products.  This team member will work with cross-functional teams in the development of post-market strategies and create documentation including the plans and reports (e.g. PMS Plans, Periodic Safety Update Reports (PSURs)), which support regulatory approvals and compliance. 

The role will require close partnership with cross-functional teams including Regulatory Affairs, Quality Engineering/Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.

Essential Job Duties

This position has responsibility for:

• Support the development of strategies that meet regulatory post-market requirements in collaboration with cross-functional teams.
• Create regulatory post-market documentation such as PMS Reports and PSURs.
• Summarize data and use methods of data presentation that improve the quality and readability of reports and documentation.
• Build relationships with key stakeholders and cross-functional partners including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.
• Apply working knowledge of European Union Medical Device Regulation (MDR) to guide project teams through the regulatory postmarket requirements.
• Demonstrate good judgement for obtaining solutions.
• Work to manage priorities and drive results with some supervision.
• Facilitate effective team collaboration by leading meetings, using software tools (e.g. Zoom, Box, Sharepoint), and developing dashboards and other communication tools.
• Draft and assemble documentation as required for internal records and regulatory submissions.
• File documentation in systems such as Agile.
• Participate in process improvement activities to continuously improve process effectiveness.
• Execute on projects as required by Manager or Director of Post Market.

Qualifications

Required Skills and Experience

A minimum of 5 years of related experience with a University degree; or 3 years experience and a Master’s degree; or a PhD without experience; or equivalent work experience.:

• Knowledge of data analysis and technical writing.
• Understanding of Medical Device Complaint files and quality record documentation.
• Understanding or experience of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDR requirements, etc.).
• Working technical and clinical medical device knowledge.

Required Education and Training

Undergraduate degree in engineering, life science, or equivalent (S.T.E.M.)

Working Conditions

None

Preferred Skills and Experience

• Review of clinical data and/or postmarket information
• Development of clinical evidence strategies
• Clinical study reports and/or publications
• Clinical evaluation of medical devices
• Medical device safety monitoring
• Ability to handle and manage workload independently.
• Ability to organize and drive meetings (in-person and remote)
• Excellent verbal and e-mail communication skills (in person and remote)
• Ability to work effectively with individuals from different backgrounds, functional areas, and/or cultures.
• Strong technical writing and ability to draft technical documentation
• Ability to understand statistical methods applied to clinical and postmarket data
• General computer skills (Excel, Word, PowerPoint, database)
• Ability to handle and manage workload with some supervision
• Prioritize numerous activities in a rapid paced environment
• Contribute to team-oriented tasks
• Analytical skills and ability to understand technical data
• Decision-making skills
• Ability to travel up to 10%, including international travel
• Fluent in English (written and spoken)

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.