Regulatory Affairs Associate

As a Regulatory Affairs Associate, you’ll join a Regulatory Affairs Operations team focused on international addendum labeling for medical devices. From your perspective, this is a chance to take ownership of labeling change work that directly supports compliance, cross-functional alignment, and timely execution across multiple geographies. You’ll collaborate with international regulatory local experts and US product owners, translating regulatory requirements into clear, accurate labeling deliverables—while helping build a centralized process that strengthens how post-approval addendum labeling is managed across the full portfolio.

Pay Range: $42/hr on W2

What's the Job?

• Design and develop international addendum labeling (IFUs, import labels, product labels, and country-specific labeling) that meets regulatory requirements for medical devices.
• Independently manage large-scale labeling change projects, including assessments to identify scope and impact to labeling.
• Coordinate labeling implementation activities by completing required forms, coordinating redlines review, and submitting labeling packages to the labeling team.
• Prepare and submit Universal Addendum Labeling (UAL) SAP packages to the Packaging, Labeling, and Program Management (PLPM) team to program addendum labeling.
• Monitor regulatory changes across international geographies, translate requirements into quality system updates, and support process improvement initiatives (e.g., change management).

What's Needed?

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry with experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering, and/or regulatory.
• Proven experience in labeling design and development from a regulatory perspective, including strong knowledge of medical device labeling requirements.
• Experience working with policies and procedures impacting documentation and documentation practices, including maintaining accurate records for approvals and audits.
• Proficiency in SAP MD and other relevant software systems, plus strong communication, collaboration, and organizational skills to manage multiple concurrent deadlines.

What's in it for me?

• Opportunity to help introduce and operationalize a new centralized process for post-approval addendum labeling across a full medical device portfolio.
• Hands-on ownership of labeling change execution, including coordination of cross-functional reviews and release activities.
• Exposure to international regulatory intelligence work—monitoring emerging issues and translating requirements into actionable updates.
• A role that values independent problem-solving, troubleshooting, and driving issues through resolution with clear mitigations.
• Direct contribution to compliance-focused documentation, audit readiness, and internal performance tracking through KPI dashboards.

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!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.