Primary Location: United States-Georgia-Norcross-US-GA-Norcross
Requisition ID: 200362
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 Regulatory Post Market Surveillance Supervisor will oversee the Regulatory Post Market Surveillance team to ensure productivity and accuracy. The Supervisor will provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and Regulatory reporting documentation. The position is responsible for overseeing regulatory reporting including MDR and Vigilance reports, to ensure alignment with procedural requirements as required. In addition, the position will provide analysis of quality data to support Regulatory Compliance activities as needed.
The Supervisor should have a strong understanding of World Wide regulatory reporting requirements for medical devices, complaint system and process requirements. A firm overall understanding of Quality System Regulations as they relate to other areas in Post Market Surveillance including CAPA and Field Actions is required. The Supervisor must demonstrate strong analytical ability required to perform thorough analysis needed to resolve or escalate complaints. A strong ability in leadership skills and strategies for providing guidance/feedback to direct reports is essential. In addition, strong project management skills and experience in continuous improvement methodologies are preferred.
Roles and Responsibilities:
• This position has responsibility and authority for:• Supervisory and leadership role within the Regulatory Post Market Surveillance team• Approve timecards and time off requests in alignment with team resource and budget requirements• Conduct 1:1 meetings with direct reports to provide guidance, development, performance feedback and opportunities for growth• Annual Performance reviews conducted for direct reports• Manage complaint workload with team to required backlog goals• Write, review, and file Medical Device Reports (MDRs) and Vigilance Reports as required.• Prepare responses to Regulatory agency requests for additional information as required.• Represent Regulatory Compliance at selected cross functional meetings• Investigating complaints:
o Perform classification of complaints and escalate complaints that require additional review.o Perform Failure Analysis investigation review and escalate complaints that require additional review.o File Regulatory Reports as identified and required (including Adverse Event and Incident related reports)o Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.o Approve MDR/MDVs, as required.o Approve final complaint file for closure after all applicable actions are completed.o Assist with customer escalations as needed
• Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.Qualifications• Analyze and trend Complaint data to identify new issues or systemic discrepancies as necessary.• Escalate complaints to the Quality or other designated organization when new failure modes are encountered.• Participate in new hire training and continuous Regulatory Compliance training as required• Participate in process improvement activities to continuously improve process effectiveness• Represent Regulatory Compliance at selected cross functional meetings• Execute on projects as required• Assist in writing or revising department procedures• Prioritize team’s tasks and meet deadlines.• Perform other duties as directed
Education: Undergraduate degree in engineering, life science, or equivalent
Experience: Minimum 5 years of experience in medical device field, with experience in the following areas:
• Supervisory or Lead experience (or equivalent) role in a Medical Device company• Strong working knowledge of Medical Device Complaint files and quality record documentation• Strong working knowledge of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD/MDR requirements, etc.)• Skills: The following skills are required for this position:• Mentor direct reports in day to day functions and career development• Demonstrate cross functional communication skills in person, by email and by phone• Strong interpersonal and organizational skills• Ability to interface cross-functionally with other groups• Independent thinker, willing to present alternative conclusions or inferences• Builds productive internal/external working relationships with all stakeholders• Ability to maintain professionalism in all types of environments• Strong verbal and written communication skills, proven ability to translate analytical• Exhibit strong leadership skills• Demonstrate strong written and verbal communication 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.