Senior Regulatory Affairs Specialist

Regulatory Affairs Senior Specialist Must be authorized to work in the U.S. without requiring employer sponsorship, now or in the future.Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at HIGHRIDGE is not just work. Life at Highridge Medical is purpose-driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves. Here at Highridge Medical, it is GO TIME, and we want people to join the growing Highridge team who have the passion to climb the next summit with us to provide patients and surgeons with the products they need. We are interested in finding someone who enjoys owning projects, interacting with a wider development team, and has submission experience. We prefer an understanding of medical devices, but if you have strong writing skills and experience in an adjacent field, drop us your resume. 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 specialists This description is not intended to be an exhaustive list of all duties and responsibilities. Duties and responsibilities may change based on business needs. The Company will evaluate the essential functions of the position in accordance with applicable law. Expected 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 regulations Education/Experience RequirementsMUST have submission writing experienceBachelor’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 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.Combination of education and experience may be considered. Travel RequirementUp to 15% Salary Range $85,000.00- $100,000.00 + Bonus DOEAbout Us