Intuitive Surgical Careers

Senior European Union Regulatory Post Market Surveillance Analyst

Regulatory and Quality

Job Description

Job: Regulatory and Quality
Primary Location: France
Schedule: Full-time
Requisition ID: 190005


Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

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 Senior EU Regulatory Post Market Surveillance Analyst will oversee the implementation and integration for Post Market elements related to the Medical Device Regulation as well as ongoing support and maintenance of the reports, procedures and requirements. This position will also be responsible for working closely with the Intuitive EU office to align on process, procedures and regulatory requirements.

Roles and Responsibilities:

This position has responsibility and authority for:

• Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulation including:

o Gap assessment of current processes and regulation requirements
o Implementation of new requirements that align and support peripheral teams and processes
o Implementation and maintenance of the Post Market Surveillance Report (PSUR)
o Implementation and maintenance of the Post Market Clinical Follow Up (PMCF)
o Implementation and maintenance of the Post Market Plan
o Analyze complaint and product failure data

• Collaboration with cross-functional teams to support EU MDR requirements, escalations, and updates. These teams include Regulatory Affairs, Clinical Affairs, Risk Management, and others as needed.
• Post Market Representation for audits as needed, including MDR certification audit
• Working closely with the Intuitive EU office to align on processes including complaint investigation, Vigilance or MIR reporting, and Competent Authority requests for additional information
• Represent Regulatory Post Market Surveillance at selected cross functional meetings
• Provide feedback and escalate any concerns or issues within the process
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Perform other duties as directed

Skill/Job Requirements:

Education - Undergraduate degree in engineering, life science, or equivalent

Experience – 10+ years of experience in the EU medical device field, with experience in the following:

  • Strong working knowledge of the EU Post Market regulation requirements
  • Proven ability to implement regulations and sustain through successful audits
  • Working knowledge of the EU Competent Authority requests
  • Supervisory or Lead experience (or equivalent) role in a Medical Device company

Skills: The following skills are required for this position:

• Demonstrate strong written and verbal communication skills
• Exhibit strong leadership skills
• 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
• 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.