Director, Clinical Affairs

Saluda Medical

Director leading clinical evidence strategy, trials, and regulatory activities for Saluda Medical's closed-loop neuromodulation devices. Driving global market access for implantable spinal cord stimulation therapy.

Posted 8/5/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical research and regulatory affairs for medical devices, with a strong focus on developing clinical evidence strategies and managing clinical trials. Proficient in synthesizing complex clinical data and ensuring compliance with FDA regulations and ICH/GCP standards.

Highest-signal resume keywords

Clinical Research Strategy DevelopmentRegulatory Affairs ExpertiseClinical Trial ManagementFDA Compliance KnowledgeData Analysis and Biostatistics

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Applicant Tracking System Keywords

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Hard Skills

Clinical Evidence StrategyClinical Trial DesignRegulatory RequirementsStatistical Analysis PlansData IntegrityResearch DesignBiostatisticsElectronic Data Capture SystemsWeb-Based Clinical Trial Management ToolsClinical Study Documentation

Soft Skills

Excellent Verbal CommunicationExcellent Written CommunicationOrganizational SkillsAttention to DetailInterpersonal Relationship Development

Industry Keywords

Active Implantable Medical DevicesNeurostimulation IndustryICH/GCPFDA Medical Device RegulationsClinical OperationsMedical AffairsQuality AssuranceHealth Economic Value InitiativesGlobal Market AccessHigh-Performance Culture

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Formulate clinical research and evidence generation strategy
Plan, implement, manage, and report applicable clinical studies and associated regulatory activities
Collaborate with Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and Operations
Enable global market access and adoption of Saluda Medical's class III implantable electrical stimulation therapy
Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity/quality
Establish detailed program plans and drive execution toward objectives
Assess risks and implement strategies to ensure successful clinical delivery
Contribute to the strategic direction and implementation of clinical affairs objectives and processes
Direct and collaborate with internal and external staff to conduct assigned clinical programs
Develop protocols, statistical analysis plans, reports, and other clinical study documentation
Support manuscripts, abstracts, data presentations, and health economic value initiatives
Promote and embody high-performance culture and behavior expectations
Lead issue identification and resolution

Requirements

What you’ll need

10+ years of direct clinical and regulatory experience in medical devices
Experience with Active Implantable Medical Devices
Minimum bachelor's degree in science, biomedical, or health-related field
Success developing clinical evidence strategies and designing and conducting clinical trials for medical devices and/or pharmaceuticals
Experience synthesizing complex clinical data into understandable written formats
Experience with neurostimulation industry preferred
Experience working with FDA and/or other regulatory and governmental agencies desired
Excellent verbal and written communication
Ability to think creatively and dynamically and foster commitment to thoughtful science
Knowledge of ICH/GCP and FDA medical device regulations
Knowledge of electronic data capture systems and web-based clinical trial management tools
Knowledge of research design, data analysis, and biostatistics
Self-motivated and able to work independently, initiate assignments, and follow through
Ability to develop interpersonal relationships with medical professionals
Excellent organizational skills and attention to detail
High degree of personal integrity
Ability to work effectively across time zones and cultures
Ability to travel domestically and internationally

Benefits

Comp & perks

Ability to work effectively across time zones and cultures
Domestic travel limited to 10% of time
International travel opportunities/requirements
Diversity and equal opportunity commitment
High-performance culture centered on customer focus, creative problem solving, transparency, and partnership