Senior compliance specialist

compliance, FDA regulations, Project Management, change management, external audits, improve process, process improvement, product development, repairs
Contract W2, 12 Months
$40 - $56

Job Description

Background of medical device and pharma ideal
2 to 5 years of experience in Post Market, Recall for Medical Device/Pharma
if not then
2 to 5 years of exp as quality eng., Post market survelliance like complaint handling
top 4 skills
1. Project Management exp
2.Agile- used by ISI as change management System
3.Understanding of FDA regulations, ISO138485 is a plus
4. Supporting audit experirnce preferred 
Bachelor's degree a must
Duration of project : 1 year
Interview strategy: 2 rounds
Need candidates who can come onsite twice a month or if not the remote who are willing to work in PST 
Actual JD::

• 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.
• Conduct Global Field Action assessments (product return, status with competent authorities) for world-wide field actions
• Support group meetings to review open tasks, provide updates, and ensure that all tasks have been assigned
• Compile and maintain recall related paper and electronic records
• Assist in recall reporting and assist in the timely initiation and communication of recalls
• 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 and review ECO’s as needed
• Prepare Field action 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 and regulatory authority response letters upon request
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Manage the Field Action in the the DVKB system and the Sales Force Alerts
• Track, reconcile, follow up, and file RMA returns and acknowledgements from customers.
• Work on legal request provided related to Field Actions
• Assist in the backroom during audits and prep folders
• Maintain audit ready resources (field action binders)
• Create and submit formal field action report for FDA, Health Canada, and distributors.
Including monthly reports and closure requests.
Dice Id : 10410924
Position Id : 7458515
Originally Posted : 1 month ago
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