Regulatory Affairs Associate

Title: Regulatory Affairs Associate
Location: Alameda, California (100% Onsite)
Duration: 8+ months
Shift Time: 8am to 5pm
Pay Range : $35/hr to $40/hr (On W2)

We are looking for a “Regulatory Affairs Associate“ to join one of our Fortune 500 clients.

Job Responsibilities:

• Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
• Assist with promotional content development and review for compliance before distribution.
• Assist in Regulatory Affairs Ad & Promo SOP development and review.
• Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed
• Determine and communicate promotional content and approval requirements to cross functional teams.
• Assist compliance with product post-marketing approval requirements as needed.

• Qualifications:

• Bachelor's degree or an equivalent combination of education and work experience 
• Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance,, research and development/support, scientific affairs, operations, or related area.
• Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Write and edit technical documents. 
• Negotiate internally. 
• Pay strong attention to detail.
• Manage projects. Create project plans and timelines.
• Think analytically and critically.
• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields. 
• Experience with review of labeling, promotional, and or advertising materials is highly desired. 
• Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.
• Office programs skills to include Word, Excel, PowerPoint, Visio and SharePoint.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button