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EU Regulatory Post Market Surveillance Lead

Job Description

Job: Regulatory and Quality
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 200010

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 Lead 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 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 Periodic Safety Update Report (PSUR)
o Implementation and maintenance of the Post Market Surveillance 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
• 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
• Perform other duties as directed
• Work on PSURs outside of EU
• Work on mapping IMDRF codes to current codes and support risk based associated activities.
• Support the PMS supervisor in complaint monitoring and reportability
• 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 – Minimum 5+ 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
Skills: The following skills are required for this position: 

• Demonstrate strong written and verbal communication skills and critical thinking
• Exhibit strong leadership skills and emotional intelligence
• 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
• Ability to influence without authority
• 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.