Senior Regulatory Affairs Specialist

This person will be joining a small, but mighty team and will have the opportunity to work on a variety of projects, focused on new product introduction, for the world’s largest privately held spine company. As an RA team member, you will work closely with project teams to develop regulatory strategies and drive those strategies to completion through submission in the US and internationally. You will have the opportunity to attend surgical labs, meet surgeons, and immerse yourself in the development process.Principal Duties and Responsibilities:Become a brand champion, owning regulatory activities for that brand, from new product introduction, to product changes and revisions, and international registration support.Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs)Provide regulatory direction for development project teams as a core team memberDevelop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutionsReview proposed labeling for compliance with applicable global regulationsReview proposed product changes for impact on regulatory status of the productsContribute to the development and maintenance of Instructions for Use and Surgical Technique GuidesReview and evaluate promotion and advertising material for compliance with applicable regulationsCommunicate with regulatory and governmental agenciesMay provide training and/or guidance to entry-level associates, analysts, interns, and specialistsSupport additional regulatory compliance items as required by regulations and as needed by the RA teamMay provide training and/or guidance to entry-level associates, analysts, interns, and specialistsExpected Areas of Competence (i.e., knowledge, skills, and abilities)Strong writing, communication, and interpersonal skillsStrong attention to detailAble to multi-task and balance competing priorities, and willingness to work with changing prioritiesSelf-motivated professional who can manage priorities and work independently in a fast-paced environmentKnowledge of overall business environment, ideally within the orthopedic industryEager to build relationships between Regulatory Affairs and other teams within the organizationAbility to communicate effectively at all levelsAdvanced knowledge of FDA, EU, and other regulatory body regulationsEducation/Experience RequirementsBachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.(Preferred) Minimum of 2 years of experience in orthopedic or medical device industry.(Required) A minimum of 5 years of experience in Regulatory Affairs, Engineering, Quality, or related field.Combination of education and experience may be considered.Travel RequirementsUp to 15%