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
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
- 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
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.