Regulatory Affairs Manager Job Listing at Kelly Services in Santa Clarita, CA (Job ID US3565734_BH9842821)

Description

Kelly® Science & Clinical is seeking a Regulatory Affairs Manager for a direct-hire position at a premier client.

• Location: Valencia & Burbank, CA (Onsite)
• Business Line: Direct Hire
• Salary Range: $100,000 - $140,000 annually (Depending on Experience)

Position Overview:

As a Regulatory Affairs Manager, you will operate under the guidance of the Director of Quality Operations to ensure compliance with the company's Quality System and Regulatory Affairs programs. This role encompasses managing multiple regulatory systems, performing internal and external audits, maintaining registrations and licensing, and overseeing regulatory submissions and documentation. You'll also lead and train teams, manage supplier audits, and support internal quality programs across the Valencia and Burbank facilities.

Key Responsibilities:

• Serve as Calibration Laboratory Management Representative.

• Maintain compliance with ISO 9001, MDSAP, FDA 21 CFR 820, EU MDR (2017/745), and other international regulations.

• Lead internal and supplier audits, issue and close CAPAs, and train internal auditors.

• Manage product registrations, certifications, and export control licensing for domestic and international markets.

• Maintain documentation control, regulatory filings, sealed source/device registries, and customer complaint programs.

• Prepare and approve controlled procedures, engineering drawings, ECOs, and capsule/package test documentation.

• Lead quality and regulatory training programs company-wide.

• Hire, supervise, appraise, and develop department staff.

• Travel between Valencia and Burbank sites and to supplier locations as needed.

Qualifications:

• Education: Bachelor's degree or equivalent in a scientific field.

• Experience:

  • 5+ years in Regulatory Affairs or a related field within medical devices or pharmaceuticals.

  • 5+ years of managerial experience.

  • Experience preparing regulatory submissions for FDA, EU MDR, and global markets.

• Skills & Competencies:

  • Certified Lead Auditor with audit and compliance expertise.

  • Proficient in Microsoft Dynamics (or similar ERP), MS Office, Teams, SharePoint.

  • Strong communication and interpersonal skills across organizational levels.

  • Able to lift up to 50 lbs and operate independently or in a team setting.

  • Strong attention to detail, planning, and adaptability in a dynamic environment.

What happens next:

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.

Join us in making a difference by applying today!
Thank you,
Kelly Team
P1#9842821

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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