Regulatory Post Market Surveillance Coordinator : 18-04612

Sunnyvale, CA 94086

Posted: 10/24/2018 Job Category: Compliance & Regulation Job Number: 11425916
Women Back to Work (WBW) candidates will also be considered for this position.
Akraya is looking for a “ Regulatory Post Market Surveillance Coordinator” for one of our clients. If the job description below is a fit, please apply directly or call Moiz at 408-816-2442. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Regulatory Reporting, Medical Device Complaint Files and Quality Record Documentation
Duration: 12+ Months
Tax Term: W2 Only

 Roles and 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.

Skill/Job Requirements:
Education: Undergraduate degree in engineering, life science, OR
Experience: 1 year of experience in Regulatory Post Market Surveillance Department with experience or exposure in the following areas:

  • 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.).
  • 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
  • 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.
      Please apply directly with your update resume or call Moiz at:  408-816-2442

About Akraya
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.

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