Regulatory Postmarket Specialist

Job Description

Primary Function of Position
The Post-Market Surveillance 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

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, sta