Regulatory Affairs Specialist

Remote • Posted 5 hours ago • Updated 5 hours ago
Contract Independent
Contract W2
Occasional Travel Required
Remote
$50 - $60/hr
Fitment

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Job Details

Skills

  • remediation
  • Medical device
  • Verification
  • Outputs

Summary

Role: Regulatory Affairs Specialist Design Controls Remediation
Location: Remote

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: 8931371
  • Posted 5 hours ago
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