Location: Louisville, Colorado
Workplace: On-site
Career Type: Full-time
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 connective tissue 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.
KEY RESPONSIBILITIES
- 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.
QUALIFICATIONS
- 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.
