Regulatory Affairs Associate

Regulatory Affairs Associate
12-Month Contract
Onsite in Alameda, CA

SUMMARY
Our client has engaged GForce Life Sciences to provide a Regulatory Affairs Associate. This position will support the Regulatory Affairs department by reviewing labeling, advertising, and promotional materials to ensure compliance and effective communication. The role involves collaborating across functions to facilitate regulatory strategy and support global submissions.

RESPONSIBILITIES

• Review and analyze labeling, advertising, and promotional materials for compliance, working with marketing teams to provide regulatory input.
• Assist with the development, review, and approval of promotional content and materials.
• Support the development and review of Regulatory Affairs Standard Operating Procedures related to advertising and promotional activities.
• Contribute to activities associated with New Product Introductions (NPI), on-market products, and regulatory submissions such as 510(k), PMA, Health Canada, and Latin American countries as needed.
• Determine and communicate promotional content approval requirements to cross-functional teams.
• Assist with post-marketing compliance activities to meet regulatory approval requirements.

MANDATORY REQUIREMENTS

• Bachelor's degree or an equivalent combination of education and work experience.
• Minimum of 2 years' experience in a regulated industry such as medical devices, pharmaceuticals, nutritionals, food, or related fields.
• Effective verbal and written communication skills.
• Ability to work cross-functionally and collaborate with diverse audiences.
• Experience with technical documentation, project management, and regulatory or quality systems.
• Strong attention to detail, analytical thinking, and organizational skills.

NICE TO HAVE

• Bachelor's degree in science, biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, engineering, or related fields.
• Up to 1 year of regulatory affairs or quality experience within the medical device industry.
• Experience reviewing labeling, promotional, or advertising materials.
• Knowledge of regulatory guidelines, policies, standards, and the structure of regulatory agencies.
• Certification such as RAC from the Regulatory Affairs Professionals Society.
• Familiarity with Office tools including Word, Excel, PowerPoint, Visio, and SharePoint.