Description
Regulatory Engineering Specialist
Location: Petaluma, CA (Onsite)
Employment Type: Contract or Contract-to-Hire
Pay Rate: $80–$90/hr
Kelly Engineering is partnering with a fast-growing medical device and pharmaceutical company that is preparing for multiple new product launches. We are seeking a Regulatory Engineering Specialist who can bridge the gap between engineering, quality, and regulatory functions. This role is ideal for someone who thrives in a startup-style environment, enjoys solving complex technical compliance challenges, and can drive results without heavy oversight.
What You'll Do-
Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and process changes.
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Prepare and support FDA submissions, including Class I device registrations, Class II 510(k) filings, and drug-related submissions.
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Develop and maintain SOPs tied to engineering processes, quality systems, and labeling compliance.
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Lead post-market surveillance activities such as complaint handling, adverse event reporting, and annual filings.
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Serve as a regulatory subject matter expert for engineering deliverables.
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Bachelor's degree in Engineering or related field (advanced degree preferred).
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5+ years of regulatory or compliance experience in medical devices, pharmaceuticals, or combination products.
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Strong working knowledge of FDA regulations, GMP, and 510(k) pathways.
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Excellent documentation and technical writing skills.
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Independent, detail-oriented professional who thrives in fast-paced environments.
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® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering 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.
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