Regulatory Affairs Specialist (Remote)

Job Summary

Principal Duties and Responsibilities

• Reviews and evaluations promotion and advertising material for compliance with applicable regulations
• Reviews proposed product changes for impact on regulatory status of the product
• Respond to requests from foreign government and/or distributors as needed
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
• Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• Evaluate risk of proposed regulatory strategies; may offer solutions
• Reviews proposed labeling for compliance with applicable global regulations
• Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams
• Communicates with regulatory and governmental agencies with supervision
• Writes and manages the development of package inserts

Expected Areas of Competence

• Knowledge of overall business environment, the orthopaedic industry, and the marketplace
• Effective negotiating skills
• Ability to identify risk in Regulatory strategies
• Knowledge of FDA, EU, and other regulatory body regulations
• Strong problem solving skills
• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
• Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
• Strong writing, communication, and interpersonal skills
• Basic computer skills, including Microsoft Office Suite
• Strong attention to detail; ability to multi-task and balance competing priorities

Education/Experience Requirements

• A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
• A combination of education and experience may be considered
• Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
• Regulatory Affairs Certification (US or EU) preferred
• A minimum of one year of experience in orthopaedic or medical device industry preferred

Travel Requirements

Additional Information