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Senior Manager of Regulatory Affairs

2 months ago

Salt Lake, Utah, United States ICU Medical Full time

Position Overview

The Regulatory Affairs Manager plays a crucial role in ensuring compliance with global and US regulations related to medical device products. This position involves analyzing regulatory requirements and tracking deliverables to support the registration process. The manager will assist in the development and maintenance of comprehensive global registration dossiers, ensuring that all documentation adheres to regulatory standards.

Key Responsibilities

· Lead and drive projects, executing strategies and plans while maintaining awareness of relevant regulations.

· Organize and prepare registration packages for medical devices, ensuring alignment with local regulatory requirements.

· Respond to inquiries from regulatory agencies under supervision, ensuring timely and accurate communication.

· Assess manufacturing and labeling modifications for their regulatory implications, providing clear descriptions for agency review.

· Collaborate with regional and country regulatory counterparts to evaluate changes and ensure compliance.

· Represent the Regulatory Affairs team in research and development meetings, articulating regulatory positions effectively.

Required Skills and Knowledge

· Review and approve critical regulatory documents, seeking guidance as necessary.

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

· Maintain a thorough understanding of global regulations to ensure compliance and minimize development costs.

· Develop and maintain regulatory strategies with oversight.

· Demonstrate sound judgment within established policies and regulations.

· Track and complete assigned registration activities, ensuring accuracy and adherence to deadlines.

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

· Provide regulatory support to product development teams and commercial initiatives with guidance.

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

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

Qualifications and 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.

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

· 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 and critical thinking skills.

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

· Must be at least 18 years of age.

Work Environment

· This position is primarily sedentary.

· Standard office equipment is routinely used.

· Travel requirements are minimal, typically less than 5%.