IVDR Regulatory Operations Specialist - SDS & eQMS

Mykelly; South San Francisco (CA); On-site; USD 48,000 - 69,000; Part time

Job summary

Kelly® Science & Clinical is seeking a Regulatory Operations Specialist for a 3-month contract with a biotechnology client. The role is onsite in South San Francisco, CA, focusing on regulatory documentation, SDS, labeling, and SOP development to ensure global compliance.

You will work with cross‑functional teams, maintain ISO 13485 and EU IVDR compliance, and support eQMS improvements while managing daily administrative tasks. Travel up to 5% may be required.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 2+ years regulatory operations in biotech or regulated sectors.
• Experience authoring SDS, SOPs, and work instructions.
• Knowledge of ISO 13485 and EU IVDR is a plus.
• Proficiency with Google Suite and Microsoft Office.
• Familiarity with eQMS and document control platforms.

Responsibilities

• Create and maintain SDS per regulatory standards.
• Collaborate with cross-functional teams to gather SDS data.
• Oversee SDS review, approval, and distribution as primary regulatory contact.
• Support eQMS improvements and system updates.
• Handle day-to-day eQMS admin tasks per policies.
• Participate in cross-functional projects and initiatives.
• Ensure activities meet ISO 13485 and regulatory guidelines.
• Occasional travel up to 5%.

Skills

Regulatory knowledge

Communication skills

Agile mindset

Collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

MasterControl

Confluence

JIRA

Job description

Kelly® Science & Clinical is seeking a Regulatory Operations Specialist for a 3-month contract with a biotechnology client. The role is onsite in South San Francisco, CA, focusing on regulatory documentation, SDS, labeling, and SOP development to ensure global compliance.

You will work with cross‑functional teams, maintain ISO 13485 and EU IVDR compliance, and support eQMS improvements while managing daily administrative tasks. Travel up to 5% may be required.