Regulatory Operations Specialist, IVDR

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. Position Title: Regulatory Operations Specialist, IVDR Position Type: 3‑month contract Pay rate: $35-50 Workplace: Onsite in South San Francisco, CA. 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 Working knowledge of medical device regulations, including ISO 13485 and EU IVDR (In Vitro Diagnostic Regulation); experience supporting regulatory documentation in an IVD or medical device environment strongly preferred. 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. #J-18808-Ljbffr Mykelly