Market Surveillance coordinator in Sunnyvale, CA at DISYS

Date Posted: 10/24/2018

Job Snapshot

Job Description

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Position:  Regulatory Post Market Surveillance Coordinator

Location: Sunnyvale, CA

Duration: 10 Months Contract

 

Roles & Responsibilities:

•        Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training as required.

•        Follow and comply with company procedures and processes relating to complaint intake, assessment and reporting.

•        Process, record and close perform assigned complaint handling activities in a timely manner.

•        Assists and supports other employees, teams and field personnel as necessary

•        Create and submit customer failure analysis letters.

•        Attach reports to complaint records; send follow up questions to customers.

•        Escalate complaints to Specialist/Analyst that require additional review.

•        Perform other duties as assigned.

Skills:

•        Basic understanding with Medical Device Complaint files and quality record documentation.

•        Basic understanding of Regulatory reporting requirements for Medical Devices (US FDA

•        requirements, EU MDD requirements, etc.). Regulatory and Quality Post Market Coordinator Intuitive Surgical, Inc. - Confidential Page 2 of 2 Users of any printed hard copy of this document must verify that it represents the most current revision prior to use

•        Basic understanding of regulatory reporting requirements for Medical Devices, complaint system, and process requirements.

•        Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices

•        Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results

•        Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines

•        Good team skills with ability to collaborate and influence

•        Excellent interpersonal skills, ability to effectively communicate and work with both

•        internal and external customers Competency / Training: The following competencies are essential for this position:

•        Orientation for focusing on details, with emphasis on accuracy and completeness

•        Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with ERP / CRM software such as SAP a plus

•        Demonstrate cross-functional communication skills in person, by email and by phone.

•        Demonstrate strong written and verbal communication skills.

•        Ability to maintain professionalism in all types of environments.

Job Requirements

Position:  Regulatory Post Market Surveillance Coordinator

Location: Sunnyvale, CA

Duration: 10 Months Contract

 

Roles & Responsibilities:

•        Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training as required.

•        Follow and comply with company procedures and processes relating to complaint intake, assessment and reporting.

•        Process, record and close perform assigned complaint handling activities in a timely manner.

•        Assists and supports other employees, teams and field personnel as necessary

•        Create and submit customer failure analysis letters.

•        Attach reports to complaint records; send follow up questions to customers.

•        Escalate complaints to Specialist/Analyst that require additional review.

•        Perform other duties as assigned.

Skills:

•        Basic understanding with Medical Device Complaint files and quality record documentation.

•        Basic understanding of Regulatory reporting requirements for Medical Devices (US FDA

•        requirements, EU MDD requirements, etc.). Regulatory and Quality Post Market Coordinator Intuitive Surgical, Inc. - Confidential Page 2 of 2 Users of any printed hard copy of this document must verify that it represents the most current revision prior to use

•        Basic understanding of regulatory reporting requirements for Medical Devices, complaint system, and process requirements.

•        Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices

•        Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results

•        Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines

•        Good team skills with ability to collaborate and influence

•        Excellent interpersonal skills, ability to effectively communicate and work with both

•        internal and external customers Competency / Training: The following competencies are essential for this position:

•        Orientation for focusing on details, with emphasis on accuracy and completeness

•        Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with ERP / CRM software such as SAP a plus

•        Demonstrate cross-functional communication skills in person, by email and by phone.

•        Demonstrate strong written and verbal communication skills.

•        Ability to maintain professionalism in all types of environments.

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.