Regulatory Specialist Sr

ManpowerGroup Global, Inc.; Alameda (CA); On-site; USD 76,000 - 80,000; Full time

Benefits offered by this job

Medical Plans

Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care FSA

Life Insurance

Disability Insurance

Travel Insurance

401(k) Plus Match

Weekly Pay

Job summary

ManpowerGroup Global, Inc. in Alameda, CA is seeking a Regulatory Specialist Sr to help ensure timely approval of medical devices and manage lifecycle regulatory activities.

You will work with cross-functional teams to develop and implement regulatory strategies and provide expert guidance on submissions and labeling. The ideal candidate brings 7+ years of regulatory affairs experience, deep knowledge of US medical device submissions, and strong collaboration skills to navigate regulatory

Qualifications

• 7+ years of experience in Medical Device Regulatory Affairs.
• Extensive knowledge of US Medical Device Submissions and regulatory change assessments.
• Strong understanding of regulations, policies, and regulatory intelligence.

Responsibilities

• Ensure timely approval of new medical devices and continued approval of marketed products.
• Participate in continuous improvement activities, product plan development, and implementation.
• Develop and execute regulatory strategies, risk management, and policy assessments.
• Serve as a regulatory representative to cross-functional teams, providing expert guidance.
• Advise development and marketing teams on manufacturing changes, line extensions, and technical labeling.

Skills

Regulatory Affairs (7+ yrs)

Job description

Job Title: Regulatory Specialist Sr

Location: Alameda, CA

Pay Range: $55/hr to $58/hr on W2

What's the Job?

• Ensure timely approval of new medical devices and continued approval of marketed products.
• Participate in continuous improvement activities, product plan development, and implementation.
• Develop and execute regulatory strategies, risk management, and policy assessments.
• Serve as a regulatory representative to cross-functional teams, providing expert guidance.
• Advise development and marketing teams on manufacturing changes, line extensions, and technical labeling.

What's Needed?

• Minimum of 7 years of experience in Medical Device Regulatory Affairs.
• Extensive knowledge of US Medical Device Submissions and regulatory change assessments.
• Strong understanding of regulations, policies, and regulatory intelligence.
• Excellent communication and collaboration skills to work effectively across teams.
• Proven ability to manage multiple projects and meet deadlines in a fast-paced environment.

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