Regulatory Operations Specialist

3-month contract opportunity with a biotechnology company in Wilsonville, OR. Pay rate: $31-42/hour, onsite.

About the role

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.

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%)

Requirements

• 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

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, and a legal plan
• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan

Pay

$31-42/hour

Schedule

3-month contract, onsite in Wilsonville, OR