Regulatory Affairs Specialist Job Listing at Kelly Services in Plymouth, MN (Job ID 9548925)

Description

Job Title: Regulatory Affairs Specialist
Location: Plymouth, MN (Hybrid: 3 days onsite per week)
Duration: 12+ Month Contract (Potential for Temp-to-Hire)
Shift: Mon-Fri, 8AM-5PM

Are you a detail-oriented Regulatory Affairs professional looking for an exciting opportunity to make an impact in the medical device industry? We are seeking a talented and motivated Regulatory Affairs Specialist to join our dynamic team in Plymouth, MN. This is a hybrid role, providing the flexibility to work both onsite and remotely, with the possibility of converting to a full-time position for the right candidate.

Key Responsibilities:

• Ensure compliance with regulatory standards (21 CFR 820, 807, 803, ISO 13485) and company policies, driving day-to-day Regulatory Affairs operations.
• Lead Post Market Surveillance (PMS) activities, including PSUR, CER, HHE, and Impact Assessments.
• Provide regulatory support for Manufacturing Plant Transition Projects, Quarterly Management Reviews, and significant/non-significant product changes.
• Collaborate cross-functionally with Quality and Design teams to review risk management plans, Health Hazard Analyses, and adverse events.
• Manage and review NCMRs, CAPAs, Reworks, product/manufacturing changes, and ensure regulatory compliance throughout the product lifecycle.
• Assist in the development of global regulatory strategies and ensure regulatory submissions meet compliance standards.
• Prepare for and support audit activities, including communication with regulatory agencies on field actions, notifications, and adverse events.
• Maintain and update Design Dossiers, Letters to Files, and assist with processing pending invoices.

What You'll Bring:

• Bachelor's degree (BS, BA) required; pursuing or holding a Master's in Regulatory Affairs is highly preferred.
• Minimum of 4 years of experience in Regulatory Affairs within the medical device industry.
• Strong leadership skills with the ability to set clear goals, provide constructive feedback, and foster a collaborative environment.
• Excellent multitasking abilities and a quick learner, able to adapt to a fast-paced, ever-changing environment.
• Outstanding verbal and written communication skills, with the ability to effectively interact at all levels of the organization.

Why Join Us?

• Opportunity to work with cutting-edge medical device products that make a real difference in healthcare.
• Collaborative and inclusive work environment with opportunities for professional growth.
• Competitive compensation and benefits with the potential for long-term employment.

If you're ready to take the next step in your regulatory affairs career, apply today and help shape the future of medical device compliance!

Apply Now
 

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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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