Regulatory Operations Specialist

Job Description

Job Description

Kelly® Science & Clinical is seeking a Regulatory Operations Specialist for a 3-month contract opportunity with one of our clients, a biotechnology company that develops and manufactures novel synthetic DNA tools at its state-of-the-art manufacturing facility in Wilsonville, OR. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Position Title: Regulatory Operations Specialist
Position Type : 3-month contract
Pay rate: $31-42
Workplace: Onsite in Wilsonville, OR
Position Overview

As a Regulatory Operations Specialist, you’ll play a pivotal role in driving the integrity and efficiency of regulatory documentation processes for cutting-edge biotechnology products. Your work ensures that scientific innovation is matched by impeccable compliance, from Safety Data Sheets (SDS) and product labeling, to well-crafted SOPs. If you thrive in a collaborative environment and are passionate about upholding the highest standards in global product compliance, we’d love to connect with you.
Key Responsibilities

• Create and maintain Safety Data Sheets (SDS) in compliance with international regulatory standards, ensuring all product documentation is up-to-date, accurate, and highly usable
• Partner with multidisciplinary teams to gather crucial data related to product composition and hazard assessments, guaranteeing completeness and consistency in SDS generation
• Oversee the end-to-end review, approval, and distribution process for SDS documents, serving as the key point of contact for regulatory documentation—internally and externally
• Support process improvements and business needs within the electronic Quality Management System (eQMS), collaborating with business process owners on system updates and configuration
• Coordinate day-to-day eQMS administrative tasks in strict alignment with company and regulatory policies
• Participate in ongoing projects and cross-functional initiatives, showcasing flexibility and adaptability
• Ensure all activities meet regulatory guidelines and ISO 13485 standards
• Occasional travel may be required (up to 5%)

Qualifications & Experience

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Biochemistry, or related field), or equivalent practical experience
• Minimum two years' experience in regulatory operations in the biotechnology, life sciences, chemical manufacturing, or other regulated sectors
• Demonstrated expertise in authoring technical documentation (SDS, SOPs, work instructions)
• Solid experience working with Quality Management Systems and electronic document control platforms (eQMS)
• Proficiency with Google Suite and/or Microsoft Office required; familiarity with MasterControl, Atlassian Confluence, and JIRA highly desirable
• Exceptional written and verbal communication skills—able to convey complex information clearly, concisely, and persuasively
• Agile mindset, with a track record of excelling in fast-paced, high-growth environments and rapidly shifting priorities

Join a passionate, forward-thinking team where your commitment to excellence shapes the future of science and safety.
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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. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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.

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