IDR, Inc. · 19 hours ago
Regulatory Affairs Specialist
United States
Full-time
Remote
Mid Level
3+ years expIDR, Inc. is seeking a Regulatory Affairs Specialist to join one of their top clients in a remote capacity. This role is pivotal in ensuring product safety and compliance with regulatory standards for medical devices, involving collaboration with various stakeholders and expert guidance to regulatory agencies.
Information TechnologyRoboticsSoftware
Responsibilities
Identify, assess, and communicate product safety risks, developing action plans to address them effectively
Ensure compliance with global medical device reporting and complaint management standards, collaborating with European Headquarters and other stakeholders
Provide expert guidance to regulatory agencies and participate in investigations of potentially reportable events, analyzing data and documentation
Track and report on all stages of the investigation process, including data analysis, documentation review, and complaint coordination
Assist with investigations, including failure analysis and corrective actions, working closely with Engineering, Manufacturing, and Quality Assurance teams
Qualification
Required
3-5 years of experience in a highly regulated environment, preferably in the medical device or pharmaceutical industries
Strong customer and service orientation with a conscientious, reliable, and independent work style
Excellent communication and conflict resolution skills, with a high sense of personal accountability
A 4-year degree or equivalent experience is required
Preferred
Experience in Quality, Product Safety, Product Surveillance, or Vigilance is preferred
Commercial or medical training preferred
Benefits
Full Benefits; Medical, Vision, Dental, and more!
Employee Stock Ownership Program
Medical, Dental, Vision, and Life Insurance
Company
IDR, Inc.
IDR, Inc.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Ashley Holahan
President and CEO
Recent News
2025-11-19
SeekingAlpha
2023-11-24
Company data provided by crunchbase