Regulatory Affairs Specialist Design Controls Remediation

Remote • Posted 2 hours ago • Updated 2 hours ago
Contract W2
Contract Independent
Remote
Depends on Experience
Fitment

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Job Details

Skills

  • Design Controls
  • Design Documentation
  • Documentation
  • Medical Devices
  • Regulatory Affairs

Summary

Role: Regulatory Affairs Specialist Design Controls Remediation

Location: Remote

Duration: 12 months

Role Summary

RA Specialists will provide regulatory oversight and subject matter expertise during design controls remediation. This role will support regulatory review of design documentation and may assist with updates to regulatory documentation where necessary.

Responsibilities

  • Provide regulatory oversight during remediation activities.
  • Review design documentation including:
  • User Needs
  • Design Inputs
  • Design Outputs
  • Design Verification and Validation
  • Design Transfer
  • Evaluate potential regulatory impact associated with remediation activities.
  • Support updates to regulatory documentation where required.
  • Provide expertise related to labeling and product claims.
  • Document regulatory review outcomes and recommendations.

Qualifications

  • Experience in Regulatory Affairs within the medical device industry.
  • Experience supporting regulatory aspects of remediation initiatives.
  • Familiarity with global regulatory requirements and regulatory submission documentation.
  • Experience with labeling, claims, and design documentation review.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10238807
  • Position Id: 8930266
  • Posted 2 hours ago
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