Regulatory Affairs Associate

Job Title: 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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.