Regulatory Operations Specialist

Kelly Services; Wilsonville (OR); On-site; USD 43,367,000 - 58,520,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Holiday pay

Job summary

Kelly Services is seeking a Regulatory Operations Specialist for a 3-month contract at our biotechnology client in Wilsonville, OR. This role focuses on regulatory documentation, SDS, labeling, and SOP development to ensure global compliance.

You’ll collaborate with cross‑functional teams, maintain eQMS tasks, author technical docs, and support ISO 13485 alignment. Requires a science degree, 2+ years in regulatory operations, and familiarity with MasterControl, Confluence, JIRA, and

Qualifications

• 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 biotech/ life sciences / chemical manufacturing
• Demonstrated expertise in authoring technical documentation (SDS, SOPs, work instructions)
• Solid experience with Quality Management Systems and electronic document control (eQMS)
• Proficiency with Google Suite and/or Microsoft Office; familiarity with MasterControl, Confluence, and JIRA
• Exceptional written and verbal communication skills—clear, concise, persuasive
• Agile mindset with success in fast-paced, high-growth environments and shifting priorities

Responsibilities

• Create and maintain Safety Data Sheets (SDS) in compliance with international standards
• Partner with cross-functional teams to gather data for SDS and hazard assessments
• Oversee end-to-end SDS review, approval, and distribution
• Support eQMS process improvements and system updates
• Coordinate day-to-day eQMS administrative tasks
• Participate in cross-functional projects and initiatives
• Ensure compliance with regulatory guidelines and ISO 13485
• Occasional travel up to 5%

Skills

Technical writing

Regulatory documentation

Communication skills

Agile mindset

Collaboration

Education

Bachelor's degree in science

Tools

eQMS

MasterControl

Confluence

JIRA

Google Workspace

Microsoft Office

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.

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.

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.

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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affluent 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.