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We are seeking a highly skilled **Regulatory Affairs Operations Specialist** to join our Regulatory Affairs team in Santa Clara, CA. This is a **6-month contract role** responsible for managing regulatory submissions and international labeling requirements for Class III implantable medical devices.

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**Location:** Santa Clara, California, USA

**Pay Rate:** $40–$42/hour (W2 Contract)

**Duration:** 6 Months (with possible extension)

Key Responsibilities

Regulatory Submissions

+ Author and submit PMA supplements including:

+ 30-Day Notices

+ Real-Time Reviews

+ 180-Day Supplements

+ Annual Reports

+ Review and approve:

+ Engineering and validation study protocols/reports

+ Manufacturing changes for Class III implantable devices

Labeling Design & Development

+ Design and implement international addendum labeling (IFUs, product/import labels)

+ Liaise with international RA affiliates and U.S. RA product owners

+ Ensure labeling meets FDA, international, and internal branding standards

+ Lead cross-functional projects and manage concurrent labeling change timelines

Labeling Implementation

+ Coordinate redline reviews and submit labeling packages to PLPM team

+ Prepare and submit SAP packages for universal addendum labeling

+ Troubleshoot issues and propose timely solutions

Regulatory Intelligence & Documentation

+ Monitor global regulatory changes and ensure compliance

+ Maintain accurate documentation for audits and regulatory reporting

+ Support preparation of KPI dashboards and internal RA metrics

Qualifications

Required

+ Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or related field

+ 4+ years of experience in a regulated industry (medical device preferred)

+ Proven track record in PMA supplement submissions and approvals

+ Strong understanding of FDA PMA guidance, CFR regulations, and Class III device requirements

+ Experience with medical device labeling and SAP systems

+ Excellent organizational, communication, and project management skills

Preferred

+ Experience with Adobe Acrobat Pro, SAP MD, and content management tools

+ Familiarity with international regulatory labeling requirements

+ Background in regulatory documentation, quality systems, and process improvements

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.