Regulatory Affairs Consultant

Santa Clara, CA, US • Posted 5 hours ago • Updated 5 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

  • FOCUS
  • Management
  • Regulatory Compliance
  • Documentation
  • Collaboration
  • Medical Devices
  • Manufacturing
  • Change Control
  • IDE
  • Regulatory Affairs

Summary

Regulatory Affairs Consultant

We are seeking an experienced Regulatory Affairs Consultant to support sustaining activities for Class III medical devices. This role will focus on assessing and managing regulatory impact of manufacturing and process changes to ensure continued compliance with global regulatory requirements.

Key Responsibilities
  • Review, assess, and document regulatory impact of manufacturing, process, and validation changes
  • Support change control activities, including regulatory strategy, submission impact assessments, and regulatory documentation updates.
  • Provide regulatory input on process validation, revalidation, and verification activities for Class III devices.
  • Collaborate with Quality, Manufacturing, and Engineering teams to ensure compliant implementation of changes.
  • Support IDE-related activities as needed, including amendments and regulatory correspondence.

Required Qualifications
  • Proven experience supporting Class III medical devices.
  • Hands-on experience reviewing and assessing manufacturing and validation change orders
  • Solid understanding of FDA regulations, Quality System Regulation (21 CFR 820), and change control processes.
  • Experience supporting IDE submissions or amendments.
PandoLogic. Keywords: Regulatory Affairs Consultant, Location: Santa Clara, CA - 95055
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: pandfeed
  • Position Id: 603686548
  • Posted 5 hours ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Sunnyvale, California

Today

Easy Apply

Third Party, Contract

$60 - $60

Sunnyvale, California

Today

Easy Apply

Contract, Third Party

Depends on Experience

Hybrid in Mountain View, California

Today

Easy Apply

Contract

60

Sunnyvale, California

Today

Easy Apply

Contract

Depends on Experience

Search all similar jobs