What are the responsibilities and job description for the Regulatory Affairs Specialist position at Kelly Science, Engineering, Technology & Telecom?
Location: Brea, CA (On-site 4 days/week) 1 day from home
Contract Duration: 2-year project contract
Rate: $35.00/hr
Position Overview
We are seeking a Regulatory Affairs Specialist contractor to join our team for a two-year project. This role will focus on global regulatory activities, including product registration submissions, facility registrations, and supporting regulatory strategy to drive market growth worldwide. The Specialist will collaborate with cross-functional teams to ensure compliance with country-specific requirements throughout product development, launch, and post-market activities.
Primary Duties & Responsibilities
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.
Get a complete career fit with Kelly®.
You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.
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.
Contract Duration: 2-year project contract
Rate: $35.00/hr
Position Overview
We are seeking a Regulatory Affairs Specialist contractor to join our team for a two-year project. This role will focus on global regulatory activities, including product registration submissions, facility registrations, and supporting regulatory strategy to drive market growth worldwide. The Specialist will collaborate with cross-functional teams to ensure compliance with country-specific requirements throughout product development, launch, and post-market activities.
Primary Duties & Responsibilities
- Stay current with regulations, including proposed and final rules from regulatory authorities, and provide regulatory support as needed.
- Create and maintain procedures, SOPs, and technical documentation to support regulatory operations.
- Assist in drafting Technical Files and compiling documentation for global product registrations.
- Implement and coordinate regulatory strategies in alignment with senior leadership.
- Prepare and maintain regulatory submissions, product registrations, certifications, and facility registrations, ensuring compliance with regional requirements.
- Work directly with distributors, in-country consultants, inter-company partners, and commercial teams to meet regulatory requirements.
- Review product, manufacturing, and labeling changes for regulatory compliance and reporting impact.
- Serve as a strategic partner in navigating complex compliance landscapes and ensuring timely product registrations.
- Bachelor’s degree (BA/BS) from a four-year college/university.
- 1 years of experience in medical devices and/or training in an FDA-regulated industry.
- Strong attention to detail, sense of urgency, and ability to prioritize multiple projects.
- Respectful, open-minded, and willing to take calculated risks to challenge the status quo.
- Accountable for work outcomes and proactive in driving positive results.
- Team player with excellent communication skills and a “can do” attitude.
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.
Get a complete career fit with Kelly®.
You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.
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.
Salary : $35