Regulatory Post Market Surveillance Field Action Specialist : 18-05005

Sunnyvale, CA 94086

Posted: 11/20/2018 Job Category: Compliance & Regulation Job Number: 11550239
      Women Back to Work (WBW)  candidates will also be considered for this position.

Akraya is looking for a "Regulatory Post Market Surveillance Field Action Specialist"  for one of our clients. If the job description below is a fit, please apply directly or call  Surbhi at  408-512-2359. 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:  Complaint handling and regulatory reporting,  Documentation, Field action activities,  US FDA requirements/EU MDD requirements
Duration: 12+ Months
W2 only 

Roles and Responsibilities: 
This position has responsibility and authority for: 
  • Assist with the Product Correction and Removal process 
  • Provide applicable data for field removals, field upgrades, tracking of customer notifications, field service repairs, and maintenance of correction documentation. 
  • Support internal and external audits for recalls as determined necessary by management. 
  • Provide manufacturing and product development with the necessary information to assess relative to product quality 
  • Assess internal department procedures and ensure they remain in compliance with applicable regulations and standards (i.E. 21CFR 806 & part 7, CMDR, MEDDEV 2.12-1, etc.)
  • Create, review and approve ECO’ s as needed 
  • Prepare PIR summaries and reports for presentation to the PIR forum for review and maintaining documentation in accordance with department policies, procedures and work instructions 
  • Compile, monitor, and report on trending of pertinent metrics, as required
  • Lead meetings for progress updates with global teams 
  • Lead kick off meetings (FAST) for new field actions 
  • Create customer response letters upon request 
  • Participate in process improvement activities to continuously improve process effectiveness 
  • Execute on projects as required 

Perform other Post Market Surveillance duties as directed 
  • Manage the Field Action in the Customer Portal feature, on the DVKB system and the Sales Force Alerts 
  • Track, reconcile, follow up, and file RMA returns and acknowledgements from customer sites 
  • Assist in the backroom during audit 
  • Maintain audit ready resources (field action binders) 
  • Create and submit formal field action report to FDA, Health Canada and distributors 
  • Work on submitting monthly reports and closure requests 
  • Assist with legal requests related to Field Actions 
 
Skill/Job Requirements: 
  • Education: Undergraduate degree in engineering, life science, or equivalent 
  • Experience: 2+ years of experience in medical device field, with experience in the following areas: 
  • Knowledge and understanding with Medical Device field actions and quality record documentation 
  • Knowledge and understanding of Regulatory reporting requirements for Medical Devices in the field action space (US FDA requirements, EU MDD requirements, etc.) 
  • Executed field actions from beginning to end with minimal guidance or supervision 
                   
      Please apply directly with your updated resume or call Surbhi at 408-512-2359

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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