Regulatory Affairs Specialist II

Regulatory Affairs Specialist II Principal Duties and Responsibilities 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 governments and/or distributors as needed. Assist with research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Provide regulatory direction to development project teams as a core team member; develop regulatory strategy for new products. Evaluate risk of proposed regulatory strategies; may offer solutions. Review proposed labeling for compliance with applicable global regulations. Write and manage the development of package inserts. Review and evaluate promotion and advertising material for compliance with applicable regulations. Review proposed product changes for impact on regulatory status of the product. Communicate with regulatory and governmental agencies with supervision. Apply FDA regulations to business practices and provide regulatory input, advice and guidance to design teams. This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA. Expected Areas of Competence 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. Build relationships between Regulatory Affairs and other areas of the organization; communicate effectively at all levels. Knowledge of FDA, EU, and other regulatory body regulations. Identify risk in regulatory strategies. Strong problem‑solving skills. Effective negotiating skills. Basic computer skills, including Microsoft Office Suite. Education / Experience Requirements Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred. Minimum of one year of experience in orthopaedic or medical device industry preferred. 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. Travel Requirements Up to 15% travel required. #J-18808-Ljbffr