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Human Resources Operations Manager

2 months ago

Salt Lake, Utah, United States ICU Medical Full time

Position Overview

The Human Resources Manager plays a pivotal role in ensuring compliance with regulatory standards and providing strategic guidance related to the global and domestic registration of medical device products. This position involves analyzing regulatory requirements and tracking deliverables to support the execution of comprehensive regulatory strategies.

Key Responsibilities

· Lead and drive projects, ensuring adherence to established strategies and plans while maintaining a thorough understanding of relevant regulations.

· Organize and prepare registration documentation for medical devices, ensuring alignment with local regulatory standards and guidelines.

· Respond to inquiries from regulatory agencies with appropriate oversight and understanding.

· Assess the impact of manufacturing and labeling modifications on regulatory compliance, providing clear descriptions for regulatory review.

· Collaborate with regional and national regulatory counterparts to evaluate changes and ensure compliance with applicable regulations.

· Represent the Global Regulatory Affairs team in research and development discussions, articulating agreed-upon regulatory positions. May serve as the primary regulatory representative for specific products or project teams.

Required Knowledge & Skills

· Review and approve critical regulatory documents, seeking guidance as necessary. Evaluate technical reports for regulatory submission readiness.

· Identify deficiencies in registration documentation and collaborate with colleagues to resolve issues.

· Possess a comprehensive understanding of global regulations to ensure compliance and minimize development costs and timelines.

· Develop and maintain regulatory strategies under supervision.

· Exercise sound judgment within established policies and regulations.

· Accountable for tracking and completing assigned registration tasks, ensuring accuracy and adherence to multiple deadlines. Delays or inaccuracies in registration can lead to significant business impacts.

· Analyze scientific arguments and identify necessary regulatory data and issues in alignment with regulatory management.

· Communicate scientific data effectively, both orally and in writing, in a clear and persuasive manner.

· Provide daily regulatory support to product development teams and commercial operations with appropriate guidance.

· Participate in the formulation of regulatory strategies, reviewing submissions and resource allocations with management prior to execution.

· Operate with minimal oversight on routine matters, exercising judgment and executing tasks in alignment with regulatory management.

Minimum Qualifications, Education & Experience

· Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering, or a related field.

· RAC Certification is preferred.

· A minimum of three years of experience in the Medical Products Industry, with at least two years in Regulatory Affairs.

· Strong analytical skills with the ability to assess scientific arguments logically.

· Proven ability to prioritize tasks and manage multiple responsibilities with minimal supervision.

· Excellent interpersonal and communication skills, both written and verbal.

· Demonstrated project management capabilities.

· Strong critical thinking, contingency planning, and negotiation skills.

· Understanding of regulatory and business needs, with the ability to engage cross-functional team members effectively.

· Must be at least 18 years of age.

Work Environment

· This role is primarily sedentary.

· The position typically utilizes standard office equipment.

· Travel requirements are minimal, generally less than 5% of the time.