Regulatory Affairs Specialist I

## Regulatory Affairs Specialist IApplylocations: US CO Westminstertime type: Full timeposted on: Posted 6 Days Agojob requisition id: JR100056Regulatory Affairs Specialist I**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 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.*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 (i.e., knowledge, skills, and abilities)*** 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**Education/Experience Requirements*** 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**Travel Requirements**Up to 15% #J-18808-Ljbffr