Regulatory Affairs Associate

Cynet Systems • Alameda, CA

1d

About The Position

The Regulatory Affairs Associate is an individual-contributor role that supports the Regulatory Affairs department in maintaining efficient, compliant business processes and an appropriate compliance environment. The associate may carry out assigned tasks and partner across business functions.

The role reviews labeling, advertising, and promotional materials; assesses risk; identifies and obtains required data; and ensures information is reliable and effectively presented to substantiate claims. The associate may also participate in worldwide regulatory submissions. This broad-scoped 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, but experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may be considered.
• Strong verbal and written communication skills, including the ability to communicate effectively with diverse audiences and personnel.
• Ability to write and edit technical documents.
• Ability to work with cross-functional teams and people from various disciplines and cultures.
• Ability to negotiate internally.
• Strong attention to detail.
• Ability to manage projects and create 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 (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, and/or advertising materials.
• Knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements, and precedents.
• Understanding of regulatory agency structure, processes, and key personnel.
• Understanding of the principles and requirements of applicable product laws, promotion, advertising, and labeling.
• Knowledge of domestic and international regulatory guidelines, policies, and regulations.
• Understanding of ethical guidelines for the regulatory profession, clinical research, and the regulatory process.
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society is a plus.
• Office program skills, including Word, Excel, PowerPoint, Visio, and SharePoint.

Responsibilities

• Review and analyze labeling, advertising, and promotional materials, working with Marketing to provide regulatory strategy and compliance input.
• Assist with developing promotional content and review it for compliance before distribution.
• Assist with development and review of Regulatory Affairs Advertising and Promotion standard operating procedures (SOPs).
• Assist with New Product Introduction and on-market product activities, including 510(k), PMA, Health Canada, and Latin America submissions, as needed.
• Determine and communicate promotional content and approval requirements to cross-functional teams.
• Assist with compliance activities related to product post-marketing approval requirements, as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level