Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord's response to stimulation and make real-time adjustments to therapy. At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.
The Post-Market Quality Specialist is responsible for the processing and management of feedback and complaints for Class III implantable spinal cord stimulation system in global markets. This role will also support Post-Market Quality data management and requests for broader QMS initiatives. The position partners closely with field teams and other quality sub-functions to ensure compliant reporting and support product performance.
Responsibilities:
- Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback, supporting all geographies
- Complaint and Feedback file management, including timely complaint intake and file closure
- Responsibility for authoring responses to regulatory agencies for additional information requests and response letters for customers following complaint reports
- Provide data inputs and analysis as needed, including monthly metrics, product trending and regulatory agency requests
- Conduct professional, HIPAA compliant, communication to internal and external parties, including end users
- Maintain and support record retention and audit readiness processes
- Participate in broader QMS initiatives and projects including supporting CAPAs and NCRs
- Drive efficiencies and process improvement for the Quality organization and cross-functionally, including frequent interaction with Supplier Quality and Customer Service
Requirements:
- Bachelor’s degree in engineering, science, technology or health OR 2+ years’ experience in the medical device industry or similar regulated environment
- Strong attention to detail, preferably with knowledge of ISO 13485 Quality Management System, database entry skills and good documentation practices
- Strong verbal communication and technical writing skills
- Individual contributor, with demonstrated organization and time management skills
- Strong aptitude for learning technical concepts
- Strong analytical and decision-making skills
- Hybrid schedule, working out of the Bloomington-MN office
Skills Required
- Bachelor's degree in engineering, science, technology or health OR 2+ years' experience in the medical device industry or similar regulated environment
- Knowledge of ISO 13485 Quality Management System
- Strong verbal communication and technical writing skills
- Strong analytical and decision-making skills
What We Do
Saluda Medical is a global company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders. The company’s first product, the Evoke® System, is the only ECAP-controlled closed-loop spinal cord stimulation (SCS) system and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Evoke System instantaneously reads, records, and responds to the nerves’ response to stimulation to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE Study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology and 24-month results have since been published JAMA Neurology. Both studies are poised to set new clinical standards for long-term pain relief and improvements in physical and emotional functioning, sleep quality and health-related quality of life. In the EU, Evoke is CE Marked and commercially available. In the U.S., Evoke is FDA-approved and will be available when the Company implements its full commercial release in 2023. Saluda Medical is a privately held company with headquarters in Bloomington, MN, USA. To learn more about Saluda Medical, including the risks & important safety information, visit www.saludamedical.com
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