Regulatory Affairs Associate

Abbott Laboratories•Alameda, CA

About The Position

As an individual contributor in Regulatory Affairs, the Regulatory Affairs Associate supports the department in maintaining efficient and compliant business processes and practices. The role involves reviewing labeling, advertising, and promotional materials; assessing risk; identifying and obtaining necessary data; and ensuring information is reliable and effectively presented to substantiate claims. The associate may execute tasks and partner across business functions, with opportunities to participate in worldwide regulatory submissions. The position offers scope 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; experience in quality assurance, research and development or support, scientific affairs, operations, or a related area may also be considered.
Effective verbal and written communication skills, including the ability to communicate 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, pay strong attention to detail, manage projects, and create project plans and timelines.
Analytical and critical-thinking skills, with the 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 a science field such as biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology; or in 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 structures, processes, and key personnel.
Knowledge of the principles and requirements of applicable product laws and of promotion, advertising, and labeling.
Knowledge of domestic and international regulatory guidelines, policies, and regulations.
Knowledge of 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 promotional content development and review content for compliance before distribution.
Assist in developing and reviewing Regulatory Affairs advertising and promotional standard operating procedures.
Assist with activities for new product introduction 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.