• Regulatory Affairs Project Manager

    Actalent (Irvine, CA)


    Job Title: Regulatory Affairs Project ManagerMUST HAVE

    + Project management expertise with 6-8+ years of experience.

    + Experience in medical device industry.

    + PMP certification or equivalent preferred.

    + Strong skills in stakeholder alignment and resource prioritization.

    + Experience with EU MDR and labeling.

    + Bachelor's Degree in Engineering.

    + 6+ years of post-graduate work experience.

    + Experience in new product introduction.

    Job Description

    Lead and manage projects for implementing manufacturing strategies for new neurovascular products, focusing on venous thromboembolism clot removal. This role requires accountability for all design transfer activities to deliver the product on time, within scope, maintaining quality, and adhering to budget constraints.

    Responsibilities

    + Manage project and product costs while proactively identifying and mitigating project risks.

    + Activate and motivate the project team to drive project success and achieve goals on time.

    + Collaborate closely with R&D, production, and suppliers to understand end-customer needs and ensure successful project implementation.

    + Innovate and improve current project management tools and PMO governance.

    + Ensure stakeholder alignment and resource prioritization.

    + Escalate employee performance and any workflow issues.

    + Review deliverables and perform spot checks.

    Work Environment

    This position is onsite in Irvine, CA. The role offers 2 weeks of PTO (burdened) and 10 client-paid holidays. The work environment emphasizes collaboration with cross-functional teams and focuses on innovation in project management processes.

    Pay and Benefits

    The pay range for this position is $60.00 - $70.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

    • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Irvine,CA.

     

    Application Deadline

     

    This position is anticipated to close on Aug 5, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.