Hiring - Regulatory Affairs Specialist – Design Controls Remediation
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Sravan Kumar
Apr 1, 2026, 2:43:38 PM (2 days ago) Apr 1
to Sravan Kumar
Role: Regulatory Affairs Specialist – Design Controls Remediation
Location: Remote
Duration: 12 months
Any Visa
Client: Hologic
Note: This is a US requirement – candidates must be authorized to work in the United States.
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.
Location: Remote
Duration: 12 months
Any Visa
Client: Hologic
Note: This is a US requirement – candidates must be authorized to work in the United States.
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.
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