Regulatory Affairs Associate

Quality

Alameda, California Contract Oct 15, 2026

Location: Alameda, CA

Onsite position. Contract role. Preferred interview method via video conference.

Position Overview Join our client as a Regulatory Affairs Associate, where you will play a key role in supporting regulatory compliance and business processes. In this position, you will review labeling, advertising, and promotional materials, ensuring that all information is accurate, reliable, and compliant with relevant standards. You will have the opportunity to collaborate with cross-functional teams and participate in worldwide regulatory submissions. This broad-scoped role offers strong potential for professional growth and career development based on your performance.

You will be responsible for analyzing promotional content, providing regulatory strategy input, and supporting the development and review of standard operating procedures. Your attention to detail and ability to manage complex information will be essential as you help ensure compliance with post-marketing approval requirements and assist with activities related to new product introductions and on-market products.

Key Responsibilities

• Review and analyze labeling, advertising, and promotional materials with Marketing teams.
• Assist with development and review of promotional content for compliance prior to distribution.
• Support Regulatory Affairs Ad & Promo SOP development and review.
• Assist with activities related to new product introductions and on-market products, including 510K, PMA, Health Canada, and Latin America submissions.
• Communicate promotional content and approval requirements to cross-functional teams.
• Support compliance with product post-marketing approval requirements.

Qualifications

• Required:
• Bachelor's degree or equivalent combination of education and work experience
• Minimum 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area preferred, but quality assurance, R&D/support, scientific affairs, operations, or related area considered.
• Effective verbal and written communication skills
• Ability to work with cross-functional teams and diverse audiences
• Technical writing and editing skills
• Internal negotiation skills
• Strong attention to detail
• Project management and planning abilities
• Analytical and critical thinking skills
• Organizational skills and ability to track complex information
• Ability to exercise judgment within defined practices and policies
• Application of business and regulatory ethical standards
• Preferred:
• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields
• 1+ year of Regulatory Affairs or Quality experience within Medical Devices
• Experience with review of labeling, promotional, and/or advertising materials
• Knowledge of regulatory and/or quality systems, guidelines, policies, standards, and requirements
• Certification such as RAC from the Regulatory Affairs Professionals Society
• Proficiency in Office programs (Word, Excel, PowerPoint, Visio, SharePoint)

Ideal Candidate The ideal candidate is detail-oriented, analytical, and able to communicate effectively with diverse teams. You thrive in a regulated environment, are comfortable managing multiple projects, and have a strong understanding of regulatory or quality requirements. Experience in medical devices and promotional material review is highly valued.

Work Schedule This is an onsite position in Alameda, CA. The preferred interview method is via video conference.

About Viltis Viltis is a trusted staffing partner, connecting talented professionals with leading organizations. We are committed to supporting your career growth and providing opportunities that align with your skills and ambitions.