Regulatory Affairs Specialist

Location: On-site or hybrid - Louisville, CO (357 S. McCaslin Blvd) Company: Synergy Spine Solutions Inc. Reports to: Vice President, Regulatory Affairs & Quality Assurance About Synergy Spine Solutions Synergy Spine Solutions is a medical device company focused on improving the quality of life for patients undergoing spine surgery. We develop motion-preserving technologies that treat degenerative disc disease while supporting the spine's natural curvature. Our flagship product, the FDA-approved Synergy Disc®, is the first and only artificial cervical disc designed to improve sagittal alignment through a built-in 6-degree lordotic core while delivering intentional motion preservation using time-tested, trusted materials. The Synergy Disc is commercially available in the United States, Europe, Australia, Canada (SAP), South Africa, and Malaysia. About the role We're seeking a mid-level Regulatory Affairs Specialist to support the global regulatory lifecycle of the Synergy Disc and future motion-preservation technologies. Working on-site in Louisville, CO, you'll maintain and expand our regulatory approvals across multiple international markets, manage post‑approval obligations for a Class III cervical disc, and supporting instrumentation. Serve as the regulatory liaison between R&D, Quality, Clinical, and our commercial and distributor teams. This is a hands‑on role with broad ownership and direct visibility across a focused, fast‑moving organization. What you’ll do Maintain and support U.S. regulatory approval for the Synergy Disc, including PMA post‑approval requirements, annual reports, and supplements for device, labeling, or manufacturing changes. Manage and expand international registrations across current and new markets (EU, Australia, Canada, South Africa, Malaysia, and others), preparing technical documentation and coordinating with in‑country representatives and distributors Support in authoring, compiling, and maintaining regulatory submissions and technical documentation, including device descriptions, risk documentation, and change assessments. Assess the regulatory impact of design, labeling, materials, and manufacturing changes, and determine submission strategy and requirements across jurisdictions. Support regulatory bodies, including FDA and international regulatory bodies, authorized reps, including responses to deficiencies and information requests. Maintain regulatory records, technical files, registrations, device listings, and establishment registration. Review labeling, packaging, surgeon‑facing materials, and marketing/promotional content for regulatory compliance across markets. Partner with Clinical to support ongoing study and post‑market data requirements stemming from the IDE/PMA pathway and international clinical trials. Monitor evolving FDA regulations, EU MDR requirements, and international standards relevant to cervical arthroplasty and Class III implants, communicating impact to the organization. Support internal and external audits and regulatory inspections. What you’ll bring Bachelor's degree in a life science, engineering, or related technical field. 3-7 years of regulatory affairs experience in the medical device industry; spinal, orthopedic, or implantable (Class III) device experience strongly preferred. Hands‑on experience with FDA submissions; PMA and post‑approval experience highly desirable (experience with 510(k) and IDE pathways a plus). Experience with international device registrations and familiarity with EU MDR technical documentation. Working knowledge of 21 CFR Part 814 (PMA), 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 risk management. Strong technical writing skills and meticulous attention to detail. Ability to manage multiple submissions and markets independently in a lean, fast‑paced environment. RAC certification a plus but not required. #J-18808-Ljbffr