Job Summary:

Assist with regulatory affairs department activities, specifically, responsible for:

Developing/revising labeling for all new and existing products.
Ensure labeling is compliant with domestic and international standards (i.e., symbols, descriptions).
Assist with new product registrations and translating approved labeling for global markets.
Create, revise and review package labeling and Instructions for Use (Clinical and Commercial).
Ability to communicate cross-functionally with Product Development, Regulatory, Quality, and Marketing to meet the needs of all labeling requirements from each department.
Manage the Instructions for Use e-copies that are available on the company website.
Assist in managing translations required for global markets.
Labeling Software validation to create or revise labels such as Nice Label.
Review clinical and commercial promotional material for distribution.
Assist FDA and International product registration and renewals.
Assist in maintaining Regulatory Affairs Registration Database regarding new registrations and renewals.
Author / Revise documents within the Quality Management system (SOPs and Work Instructions).
Assist with departmental administrative duties.

Qualifications:

Based on new international standards, determine if labeling updates are required and how they will impact international regulatory filings.
Ability to identify regulatory claims
Minimum 2-3 years of experience in Regulatory Affairs.
Bachelor’s Degree (minimum)
Well-versed in global labeling requirements in geographical areas such as the European Union, and MDSAP Countries, and an understanding of additional international countries.
Organizational, prioritization, and communication cross-functionally.
Strong background in Microsoft Office
Experience Validating or Using Software

Regulatory Associate