Regulatory Postmarket Specialist

Primary Function of Position

The PostMarket Surveillance Report Specialist provides expertise and support for the development of postmarket strategies plans and reports for new and existing Intuitive products.  This team member will work with crossfunctional teams in the development of postmarket 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 crossfunctional 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 postmarket requirements in collaboration with crossfunctional teams.
• Create regulatory postmarket 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 crossfunctional 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 Masters 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 (inperson and remote)
• Excellent verbal and email 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 teamoriented tasks
• Analytical skills and ability to understand technical data
• Decisionmaking 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 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