Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

• 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.

• Respond to requests from foreign government and/or distributors as needed

• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products

• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

• Evaluate risk of proposed regulatory strategies; may offer solutions

• Reviews proposed labeling for compliance with applicable global regulations

• Writes and manages the development of package inserts

• Reviews and evaluations promotion and advertising material for compliance with applicable regulations

• Reviews proposed product changes for impact on regulatory status of the product

• Communicates with regulatory and governmental agencies with supervision

• Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.

• Strong writing, communication, and interpersonal skills

• Strong attention to detail; ability to multi-task and balance competing priorities

• Knowledge of overall business environment, the orthopaedic industry, and the marketplace

• 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

• Knowledge of FDA, EU, and other regulatory body regulations

• Ability to identify risk in Regulatory strategies

• Strong problem solving skills

• Effective negotiating skills

• Basic computer skills, including Microsoft Office Suite

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred

• A minimum of one year of experience in orthopaedic or medical device industry preferred

• A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required

• Regulatory Affairs Certification (US or EU) preferred

• A combination of education and experience may be considered