Sr. Regulatory Affairs Specialist
About Spinal Elements
Spinal 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
Meet 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:
What Makes you Successful (KSA’s):
What You’ll Get (Benefits & Perks)
Education 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 Authorization
US Work Authorization required
Work Environment
This job operates in an office setting.
Compensation
Pay range: $100,000 to $120,000 annual base salary.
Physical Demands
While 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.
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