Regulatory Post Market Surveillance Supervisor

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 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 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 :

Perform classification of complaints and escalate complaints that require additional review.

Qualifications :

Skill / Job Requirements :

Education : Undergraduate degree in engineering life science or equivalent

Experience : 7 years of experience in medical device field with experience in the following areas :

Skills : The following skills are required for this position :

Additional Information :

Intuitive is an Equal Employment 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.

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

Intuitive is an Equal Employment 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.

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

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.

Remote Work : No

Employment Type : Full-time

Key Skills

IT Sales and Marketing,Instrument Maintenance,IT Service Management,Insurance,Chemical

Experience : years

Vacancy : 1