Regulatory Postmarket Specialist

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
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 (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 state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time