Regulatory Affairs Associate

generis Tek • Alameda, CA

1d • Onsite

About The Position

Generis Tek is recruiting a Regulatory Affairs Associate for a client in Alameda, California. This is an on-site, 10+ month contract role, with a Monday–Friday schedule from 8:00 AM to 5:00 PM and a pay rate of $39.50 per hour on W2.

As an individual contributor supporting the Regulatory Affairs department, the associate will help maintain efficient, compliant business processes. The role involves reviewing labeling, advertising, and promotional materials; assessing risk and identifying and obtaining reliable data to substantiate claims; and partnering with cross-functional teams. The associate may also participate in worldwide regulatory submissions and support new and marketed products. The position offers opportunities for growth and career development based on performance.

Requirements

• Bachelor's degree or an equivalent combination of education and work experience.
• At least 2 years of experience in a regulated industry, such as medical products, nutritionals, pharmaceuticals, or food. Regulatory experience is preferred; relevant quality assurance, research and development/support, scientific affairs, operations, or related experience may be considered.
• Effective verbal and written communication, including the ability to communicate with diverse audiences and personnel.
• Ability to work with cross-functional teams and people from different disciplines and cultures.
• Ability to write and edit technical documents.
• Ability to negotiate internally.
• Strong attention to detail.
• Project management skills, including creating project plans and timelines.
• Analytical and critical-thinking skills.
• Ability to organize and track complex information.
• Ability to exercise judgment within generally defined practices and policies when selecting methods and techniques to obtain solutions.
• Ability to apply business and regulatory ethical standards.

Nice To Haves

• Bachelor's degree in science (such as biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology), regulatory affairs, engineering, or a medical field.
• At least 1 year of Regulatory Affairs or Quality experience within medical devices.
• Experience reviewing labeling, promotional, or advertising materials.
• Knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements, and precedents.
• Knowledge of regulatory agency structure, processes, and key personnel; applicable product laws; promotion, advertising, and labeling requirements; domestic and international regulatory guidance and regulations; and ethical guidelines for the regulatory profession, clinical research, and regulatory processes.
• Regulatory Affairs certification, such as RAC from the Regulatory Affairs Professionals Society.
• Proficiency with Word, Excel, PowerPoint, Visio, and SharePoint.

Responsibilities

• Review and analyze labeling, advertising, and promotional materials, partnering with Marketing to provide regulatory strategy and compliance input.
• Assist with the development and compliance review of promotional content before distribution.
• Assist in developing and reviewing Regulatory Affairs advertising and promotion standard operating procedures.
• Support activities related to new product introductions and marketed products, including 510(k), PMA, Health Canada, and Latin American country submissions, as needed.
• Determine and communicate promotional content and approval requirements to cross-functional teams.
• Assist with compliance with product post-marketing approval requirements, as needed.
• Assess risk and identify, obtain, and evaluate data to substantiate claims and ensure information is reliably and effectively presented.
• Partner across business functions and contribute to efficient, compliant Regulatory Affairs processes.

What This Job Offers

• Career Level: Entry Level