Description
Kelly Services is proud to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion).
Principal, Regulatory Affairs – IVD / Medical Devices
Location: Norcross, GA
Industry: Medical Devices / In Vitro Diagnostics
Pay: $100k-$130k
About the Role
We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market regulatory activities for medical devices, including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA, Health Canada, and EU Notified Body requirements, providing regulatory guidance throughout product development and launch.
This position serves as a key regulatory partner on design teams, authors regulatory submissions, reviews product labeling and commercial materials, and interfaces with regulatory agencies to ensure compliance.
Key Responsibilities
• Serve as regulatory representative on design teams for new products and significant product modifications.
• Develop global regulatory plans, advising on product classification, registration paths, and commercial strategy alignment.
• Prepare and submit regulatory filings, including US FDA 510(k), Health Canada licenses, and EU Notified Body submissions.
• Author summary analytical and clinical reports, and coordinate submission deliverables with R&D and Marketing.
• Review and approve commercial materials (brochures, presentations, training materials) for regulatory compliance.
• Maintain awareness of regulatory requirements across the US, Canada, and EU, and support ongoing product launches.
• Perform other regulatory activities as needed to support compliance and successful market entry.
Qualifications
• Bachelor's degree in regulatory science, life sciences, or related field (advanced degree preferred).
• Minimum 8 years of regulatory affairs experience in medical devices, preferably with IVD experience.
• Hands-on experience preparing submissions to US FDA, Health Canada, and EU Notified Bodies within the past 8 years.
• Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to EU MDR/IVDR.
• Strong writing, verbal communication, and organizational skills.
• Ability to prioritize multiple projects in a fast-paced environment with minimal supervision.
• English fluency required; international travel 5–10% per year.
Additional Details
• Travel Requirement: 5–10% domestic and international
• Employment Type: Full-time, permanent
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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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