Regulatory Associate NEW

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