Manager, Clinical Affairs

Saluda Medical

. Contribute to formulating the clinical research and evidence generation strategy .

Posted 11/3/2026full-timeRemote • Minnesota • United StatesMid-LevelSeniorWebsite

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 clinical trial design, data analysis, and compliance with FDA regulations. Proven ability to collaborate across diverse teams and drive program execution to meet strategic objectives.

Highest-signal resume keywords

Clinical Research StrategyRegulatory Affairs ExperienceClinical Trial DesignFDA Regulations KnowledgeData Analysis and Biostatistics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DocumentationClinical Quality System DevelopmentRisk Assessment and ManagementStatistical Analysis PlansClinical Trials ExecutionEvidence Generation StrategyData Integrity and QualityResearch DesignHealth Economic Value InitiativesInterpersonal Relationship Development

Soft Skills

Excellent Verbal and Written CommunicationCreative Problem SolvingOrganizational SkillsSelf-Motivated Work StyleCultural Sensitivity

Tools & Technologies

Electronic Data Capture SystemsWeb-Based Clinical Trial Management Tools

Industry Keywords

Active Implantable Medical DevicesNeurostimulation IndustryICH/GCP KnowledgeClinical OperationsMedical Affairs

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Contribute to formulating the 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 a Class III implantable electrical stimulation therapy
Drive program execution to meet customer needs and financial goals
Create and uphold a high-performance culture centered on customer focus, creative problem solving, transparency, and partnership
Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity/quality
Establish detailed program plans and drive execution toward established objectives
Assess risk and implement strategies to ensure successful delivery of clinical objectives
Direct and collaborate with internal and external staff and liaise with partner sites and physicians
Develop protocols, statistical analysis plans, reports, and other clinical study documentation
Contribute to strategic direction for clinical affairs objectives and processes
Support manuscripts, abstracts, data presentations, and health economic value initiatives
Lead issue identification and resolution

Requirements

What you’ll need

5+ years direct clinical and regulatory experience in medical devices, including some experience with Active Implantable Medical Devices
Demonstrated success in designing and conducting clinical trials in support of medical devices and/or pharmaceuticals
Experience with neurostimulation industry preferred
Experience working with FDA and/or other regulatory and governmental agencies desired
Experience synthesizing complex clinical data into understandable written format
A minimum of a Bachelor’s degree in science, biomedical, or health-related field
Masters or PhD preferred
Ability to work effectively across time zones and cultures
Ability to travel domestically (10% of time) and internationally
Excellent verbal and written communication
Knowledge of ICH/GCP and FDA medical device regulations
Knowledge of research design, data analysis, and biostatistics
Ability to develop good interpersonal relationships with medical professionals
High degree of personal integrity
Excellent organizational skills and attention to detail
Self-motivated and independent work style with the ability to initiate and follow through on assignments
Knowledge of electronic data capture systems and web-based clinical trial management tools
Ability to think creatively and dynamically and foster a culture of commitment to thoughtful science

Benefits

Comp & perks

Ability to work effectively across time zones and cultures
Ability to travel domestically (10% of time) and internationally
Diversity and equal opportunity workplace commitment