Regulatory Affairs Associate

Pay Range: $36.18hr - $41.18hr

Job Overview:

As an individual contributor in the role of a Regulatory Affairs Specialist, the candidate will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will review Labeling, Advertising, and Promotional materials, determine risk, identify required data, obtain data, and ensure that the information is reliable and effectively presented to substantiate claims. The successful candidate will also have opportunities to participate in worldwide regulatory submissions. This is a broad-scoped position with strong opportunity for growth and career development based on performance.

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 Advertising and Promotion Standard Operating Procedure (SOP) development and review.
• Assist with activities related to New Product Introduction (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.

Required Qualifications:

• Bachelor's degree or an equivalent combination of education and work experience.
• Minimum of 2+ years of 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.
• Strong verbal and written communication skills.
• Ability to communicate effectively with diverse audiences and personnel.
• Write and edit technical documents.
• Work with cross-functional teams and with people from various disciplines and cultures.
• Negotiate internally.
• Pay strong attention to detail.
• Manage projects, creating project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Apply business and regulatory ethical standards.

Preferred Qualifications:

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
• 1+ years of Regulatory Affairs or Quality experience within Medical Devices is preferred.
• Experience with review of labeling, promotional, and/or advertising materials is highly desired.
• 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 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 of the regulatory profession, clinical research, and regulatory process.
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society is a plus.
• Office program skills to include Word, Excel, PowerPoint, Visio, and SharePoint.