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EU PM Surveillance Analyst

Job Description

Job: Regulatory and Quality
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 200366

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and
decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

The EU Regulatory Post Market Surveillance Analyst will be responsible for data analysis, trending and communicating the Post Market elements related to the EU Medical Device Regulation as well as ongoing support and maintenance of the Post-Market reports, procedures and other requirements, as needed. This position will also be responsible for working closely with other Data Analytics, Advanced Failure Analysis and Customer Service groups to understand and help improve data analysis and trending.

Roles and Responsibilities:

This position has responsibility for:

• Data analysis and Trending of complaint and failure analysis data for use within Quality Data Review, Post-Market Surveillance Reports and other
• Responsible for writing Technical Reports:
• Post-Market Surveillance Reports (PSURs, PMSRs)
• EU MDR
• New Regions (China, etc.)
• Regulatory Inquiries
• Will serve as a Representative or Lead for
• Quality Data Review Meetings (Complaint or Failure Trending, etc.)
• Collaborative meetings with internal Post-Market teams (PM Clinical Development Engineering, Continuous Improvement Quality Engineering, Post-Market Investigation, etc.) for understanding the impacts of Moderate Change Forms, CAPAs, Field Actions with respect to Post-Market reporting.
• Additional Tasks as required supporting Post-Market Complaint and Investigation Teams (Complaint Handling, Mapping Risk to Complaints, DHR Review, Failure Analysis Investigation Reports, etc.)
• Execute on projects as required by Manager or Director of Post Market, Sunnyvale


Qualifications

Skill/Job Requirements:

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

Experience – 3+ years of experience in the Medical Device field, with experience in the following:
 Strong working knowledge of data analysis and technical writing
 Proven ability to work cross-functionally
 Working knowledge and understanding with Medical Device Complaint files and quality record documentation.
 Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDR requirements, etc.).
 Working technical and clinical medical device knowledge

Skills: The following skills are required for this position:

• Demonstrate strong written and verbal communication skills and critical thinking
• Strong computer skills (Excel, Word, PowerPoint, database)
• Efficient independent worker with ability to focus
• Attention to detail
• Ability to lead meetings or cross functional teams to come to resolution when facing ambiguous situations
• Demonstrate cross functional communication skills in email and in person
• Excellent organizational and analytical skills
• Ability to handle and manage workload independently
• Prioritize numerous activities in a rapid paced environment
• Contribute to team oriented tasks


We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.