Regulatory Affairs Associate
$35 - $40 per hourExperis/Manpower Group
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:
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.
Vacancy posted 4 days ago
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