Regulatory Affairs Manager

2 weeks ago

Salt Lake, Utah, United States ICU Medical Full time

Position Overview

The Regulatory Affairs Manager plays a crucial role in providing support and direction related to the global and US registration of medical device products. This position involves analyzing regulatory requirements and monitoring deliverables to ensure compliance. The manager will assist in the development and maintenance of comprehensive global registration dossiers while ensuring that all documentation meets regulatory standards for submissions and change management.

Key Responsibilities

· Spearheads projects and implements agreed strategies with appropriate oversight, maintaining a thorough understanding of relevant regulations.

· Organizes and prepares registration packages for medical devices, ensuring alignment with local regulatory standards and guidelines.

· Responds to inquiries from regulatory agencies with guidance and oversight.

· Assesses manufacturing and labeling modifications for their regulatory implications, providing clear descriptions to facilitate agency reviews.

· Collaborates with regional and national regulatory counterparts to evaluate changes and ensure adherence to applicable regulations.

· Represents the Global Regulatory Affairs team in research and development discussions, articulating regulatory positions effectively.

Required Knowledge & Skills

· Reviews and approves essential documents, seeking advice when necessary, and evaluates technical reports for regulatory submission readiness.

· Identifies deficiencies in registration documentation and collaborates with colleagues to resolve issues.

· Maintains a strong understanding of global regulations to ensure compliance, thereby minimizing development costs and timelines.

· Develops and maintains regulatory strategies under supervision.

· Exercises sound judgment in accordance with policies and regulations.

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

· Engages with scientific data and identifies regulatory needs in alignment with management.

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

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

· Participates in the formulation of regulatory strategies, reviewing submissions and changes with management prior to execution.

· Operates with minimal oversight on routine matters, making informed decisions aligned with regulatory management.

Qualifications & Experience

· A Bachelor's Degree is 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.

· Ability to analyze scientific arguments and apply logical reasoning.

· Strong prioritization and multitasking skills with minimal supervision.

· Excellent interpersonal, oral, and written communication skills.

· Proven project management capabilities.

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

· Understanding of regulatory and business requirements, with the ability to engage cross-functional teams.

· Must be at least 18 years of age.

Work Environment

· This role is primarily sedentary.

· Standard office equipment is routinely used.

· Travel requirements are typically less than 5%.

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