Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs SpecialistAbout Spinal ElementsSpinal Elements is a Carlsbad, California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies. Learn more at the Team:The Senior Regulatory Affairs Specialist is a key member of the Regulatory Affairs team and reports to the Associate Director, Regulatory Affairs. This role is responsible for ensuring compliance with applicable regulations and supporting the development and approval of medical devices. The Regulatory Affairs team at Spinal Elements plays a critical role in maintaining regulatory compliance, liaising with regulatory agencies, and providing strategic guidance on regulatory requirements. Additionally, the team works closely with cross-functional departments to support product development, submissions, and post-market surveillance activities.About the Role:The Senior Regulatory Specialist is responsible for the coordination and preparation of document packages for regulatory submissions for new and mature products, ensuring alignment and compliance with local, regional, and global registration requirements, as well as company policies. Reporting to the Associate Director of Regulatory Affairs, this role actively participates in Quality System compliance, leads regulatory strategy development, and provides expert guidance on compliance initiatives. The Senior Specialist plays a crucial role in direct interactions with regulatory agencies and serves as a mentor to junior regulatory professionals.Primary Responsibilities Include:Lead and oversee regulatory submission processes, ensuring successful approval and compliance.Develop and implement regulatory strategies to streamline submission pathways and optimize approval timelines.Manage and facilitate direct interactions with regulatory agencies on complex regulatory matters.Mentor and train junior regulatory professionals, fostering expertise and regulatory knowledge within the team.Serve as regulatory representative on new product development teams.Provide high-level recommendations on labeling, manufacturing, marketing, and clinical protocols to maintain compliance and for new product development.Actively drive continuous improvement in regulatory documentation processes and tracking systems.Monitor industry changes and proactively assess regulatory impact on business operations.Lead Quality System compliance efforts, supporting internal/external audits, CAPA and policy development.Support and guide clinical trial application submissions, ensuring alignment with strategic objectives.What Makes you Successful (KSA’s):Strong leadership and ability to influence regulatory strategy at an organizational level.Advanced expertise in regulatory submissions (510(k), PMA), UDI and compliance processes for medical devices.Knowledge of international regulatory frameworks (Australia, , Europe, Mexico, Brazil).Strong decision-making skills in complex regulatory matters.Expertise in ISO 13485, 21 CFR 820, MDSAP, and MDR regulations.Ability to analyze regulatory updates and provide proactive strategic solutions.High attention to detail with the ability to manage multiple high-priority projects.Proficiency in regulatory documentation systems and compliance tracking tools.Experience leading audits and compliance initiatives.What You’ll Get (Benefits & Perks)A full and comprehensive benefits program including medical, dental, vision, short term and long-term disability, flexible spending accounts, and moreWellness program and Employee Assistance Program (EAP)Retirement savings plan (401k) with 4% company matchEducational reimbursement programTravel Assistance Program, Pet Insurance and Legal Services10 paid company holidays and 1 floating holiday15 days PTOEducation and Experience:Bachelor’s degree required; advanced degree preferred.5+ years of regulatory affairs experience in the medical device industry or a closely related field.Travel: Minimal travel required (less than 10%)Work AuthorizationUS Work Authorization requiredWork EnvironmentThis job operates in an office setting.CompensationPay range: $100,000 to $120,000 annual base salary.Physical DemandsWhile performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.The employee will be required to perform duties at a computer workstation on a computer and phone. Must be able to lift up to 50 pounds to prepare specimens and surgical set for events.Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Created: 2025-07-04