Regulatory Affairs Associate

Regulatory Affairs Associate

Location: Santa Clara, CA

Mode: 12 Months Contract / 100% Onsite

Pay Range: $42 to $46/hr on W2

What's the Job?

• Manage regulatory labeling processes, including addendum and supplemental labeling updates
• Prepare and submit applications for government approvals, including PMA supplements and annual reports
• Review and approve engineering and validation study protocols and reports
• Oversee manufacturing change approvals for Class III implantable medical devices
• Maintain compliance with FDA regulations and guidance documents related to medical devices

What's Needed?

• Minimum of 5+ years of experience in Regulatory Affairs within the medical device industry
• Hands-on experience with regulatory labeling, especially addendum and supplemental labeling
• Familiarity with regulated medical device environments and quality systems
• Proven track record of authoring and submitting PMA supplements for Class III implantable devices
• Knowledge of FDA PMA guidance documents and CFR regulations

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay